text:
Control Systems/Glossary

The following is a listing of some of the most important terms from the book, along with a short definition or description.

A, B, C

 * Acceleration Error:The amount of steady state error of the system when stimulated by a unit parabolic input.
 * Acceleration Error Constant:A system metric that determines that amount of acceleration error in the system.
 * Adaptive Control:A branch of control theory where controller systems are able to change their response characteristics over time, as the input characteristics to the system change.
 * Adaptive Gain: when control gain is varied depending on system state or condition, such as a disturbance
 * Additivity:A system is additive if a sum of inputs results in a sum of outputs.
 * Analog System:A system that is continuous in time and magnitude.
 * ARMA: Autoregressive Moving Average, see
 * ATO: Analog Timed Output. Control loop output is correlated to a timed contact closure.
 * A/M: Auto-Manual.  Control modes, where auto typically means output is computer-driven, calculated while manual can be field-driven or merely using a static setpoint.

 * Bilinear Transform: a variant of the Z-transform, see
 * Block Diagram:A visual way to represent a system that displays individual system components as boxes, and connections between systems as arrows.
 * Bode Plots:A set of two graphs, a "magnitude" and a "phase" graph, that are both plotted on log scale paper. The magnitude graph is plotted in decibels versus frequency, and the phase graph is plotted in degrees versus frequency. Used to analyze the frequency characteristics of the system.
 * Bounded Input, Bounded Output:BIBO. If the input to the system is finite, then the output must also be finite. A condition for stability.

 * Cascade: When the output of a control loop is fed to/from another loop.
 * Causal:A system whose output does not depend on future inputs. All physical systems must be causal.
 * Classical Approach:See Classical Controls.
 * Classical Controls:A control methodology that uses the transform domain to analyze and manipulate the Input-Output characteristics of a system.
 * Closed Loop:a controlled system using feedback or feedforward
 * Compensator:A Control System that augments the shortcomings of another system.
 * Condition Number:
 * Conditional Stability:A system with variable gain is conditionally stable if it is BIBO stable for certain values of gain, but not BIBO stable for other values of gain.
 * Continuous-Time:A system or signal that is defined at all points t.
 * Control Rate: the rate at which control is computed and any appropriate output sent. Lower bound is sample rate.
 * Control System:A system or device that manages the behavior of another system or device.
 * Controller:See Control System.
 * Convolution:A complex operation on functions defined by the integral of the two functions multiplied together, and time-shifted.
 * Convolution Integral:The integral form of the convolution operation.
 * CQI: Control Quality Index, $$=1-abs(PV-SP)/max[PVmax-SP,SP-PVmin]$$, 1 being ideal.
 * CV: Controlled variable

D, E, F

 * Damping Ratio:A constant that determines the damping properties of a system.
 * Deadtime: time shift between the output change and the related effect (typ. at least one control sample). One sees "Lag" used for this action sometimes.
 * Digital:A system that is both discrete-time, and quantized.
 * Direct action: target output increase is required to bring the process variable (PV) to setpoint (SP) when PV is below SP.  Thus, PV increases with output increase directly.
 * Discrete magnitude:See quantized.
 * Discrete time:A system or signal that is only defined at specific points in time.
 * Distributed:A system is distributed if it has both an infinite number of states, and an infinite number of state variables. See Lumped.
 * Dynamic:A system is called dynamic if it doesn't have memory. See Instantaneous, Memory.

 * Eigenvalues:Solutions to the characteristic equation of a matrix. If the matrix is itself a function of time, the eigenvalues might be functions of time. In this case, they are frequently called eigenfunctions.
 * Eigenvectors:The nullspace vectors of the characteristic equation for particular eigenvalues. Used to determine state-transitions, among other things. See
 * Euler's Formula:An equation that relates complex exponentials to complex sinusoids.
 * Exponential Weighted Average (EWA): Apportions fractional weight to new and existing data to form a working average. Example EWA=0.70*EWA+0.30*latest, see Filtering.
 * External Description:A description of a system that relates the input of the system to the output, without explicitly accounting for the internal states of the system.

See
 * Feedback:The output of the system is passed through some sort of processing unit H, and that result is fed into the plant as an input.
 * Feedforward: whwn apriori knowledge is used to forecast at least part of the control response.
 * Filtering (noise): Use of signal smoothing techniques to reject undesirable components like noise. Can be as simple as using exponential weighted averaging on the input.
 * Final Value Theorem:A theorem that allows the steady-state value of a system to be determined from the transfer function.
 * FOH:First order hold
 * Frequency Response:The response of a system to sinusoids of different frequencies. The Fourier Transform of the impulse response.
 * Fourier Transform:An integral transform, similar to the Laplace Transform, that analyzes the frequency characteristics of a system.

G, H, I

 * Game Theory:A branch of study that is related to control engineering, and especially optimal control. Multiple competing entities, or "players" attempt to minimize their own cost, and maximize the cost of the opponents.
 * Gain:A constant multiplier in a system that is typically implemented as an amplifier or attenuator. Gain can be changed, but is typically not a function of time. Adaptive control can use time-adaptive gains that change with time.
 * General Description:An external description of a system that relates the system output to the system input, the system response, and a time constant through integration.

 * Hendrik Wade Bode:Electrical Engineer, did work in control theory and communications. Is primarily remembered in control engineering for his introduction of the bode plot.
 * Harry Nyquist:Electrical Engineer, did extensive work in controls and information theory. Is remembered in this book primarily for his introduction of the Nyquist Stability Criterion.
 * Homogeniety:Property of a system whose scaled input results in an equally scaled output.
 * Hybrid Systems:Systems which have both analog and digital components.

 * Impulse:A function denoted δ(t), that is the derivative of the unit step.
 * Impulse Response:The system output when the system is stimulated by an impulse input. The Inverse Laplace Transform of the transfer function of the system.
 * Initial Conditions:The conditions of the system at time $$t = t_0$$, where t0 is the first time the system is stimulated.
 * Initial Value Theorem:A theorem that allows the initial conditions of the system to be determined from the Transfer function.
 * Input-Output Description:See external description.
 * Instantaneous:A system is instantaneous if the system doesn't have memory, and if the current output of the system is only dependent on the current input. See Dynamic, Memory.
 * Integrated Absolute Error (IAE):absolute error (ideal vs actual performance) is integrated over the analysis period.
 * Integrated Squared Error (ISE):squared error (ideal vs actual performance) is integrated over the analysis period.
 * Integrators:A system pole at the origin of the S-plane. Has the effect of integrating the system input.
 * Inverse Fourier Transform:An integral transform that converts a function from the frequency domain into the time-domain.
 * Inverse Laplace Transform:An integral transform that converts a function from the S-domain into the time-domain.
 * Inverse Z-Transform:An integral transform that converts a function from the Z-domain into the discrete time domain.

J, K, L

 * Lag: The observed process impact from an output is slower than the control rate.
 * Laplace Transform:An integral transform that converts a function from the time domain into a complex frequency domain.
 * Laplace Transform Domain:A complex domain where the Laplace Transform of a function is graphed. The imaginary part of s is plotted along the vertical axis, and the real part of s is plotted along the horizontal axis.
 * Left Eigenvectors:Left-hand nullspace solutions to the characteristic equation of a matrix for given eigenvalues. The rows of the inverse transition matrix.
 * Linear:A system that satisfies the superposition principle. See Additive and Homogeneous.
 * Linear Time-Invariant: LTI. See Linear, and Time-Invariant.
 * Low Clamp: User-applied lower bound on control output signal.
 * L/R: Local/Remote operation.
 * LQR: Linear Quadratic Regulator.
 * Lumped:A system with a finite number of states, or a finite number of state variables.

M, N, O

 * Magnitude: the gain component of frequency response. This is often all that is considered in saying a discrete filter's response is well matched to the analog's.  It is the DC gain at 0 frequency.
 * Marginal Stability:A system has an oscillatory response, as determined by having imaginary poles or imaginary eigenvalues.
 * Mason's Rule: see
 * MATLAB: Commercial software having a Control Systems toolbox. Also see Octave.
 * Memory:A system has memory if its current output is dependent on previous and current inputs.
 * MFAC:Model Free Adaptive Control.
 * MIMO:A system with multiple inputs and multiple outputs.
 * Modern Approach:see modern controls
 * Modern Controls:A control methodology that uses the state-space representation to analyze and manipulate the Internal Description of a system.
 * Modified Z-Transform:A version of the Z-Transform, expanded to allow for an arbitrary processing delay.
 * MPC: Model Predictive Control.
 * MRAC: Model Reference Adaptive Control.
 * MV: can denote Manipulated variable or Measured variable (not the same)

 * Natural Frequency:The fundamental frequency of the system, the frequency for which the system's frequency response is largest.
 * Negative Feedback:A feedback system where the output signal is subtracted from the input signal, and the difference is input to the plant.
 * The Nyquist Criteria:A necessary and sufficient condition of stability that can be derived from Bode plots.
 * Nonlinear Control:A branch of control engineering that deals exclusively with non-linear systems. We do not cover nonlinear systems in this book.

 * OCTAVE: Open-source software having a Control Systems toolbox. Also see MATLAB.
 * Offset: The discrepancy between desired and actual value after settling. P-only control can give offset.
 * Oliver Heaviside:Electrical Engineer, Introduced the Laplace Transform as a tool for control engineering.
 * Open Loop: when the system is not closed, its behavior has a free-running component rather than controlled
 * Optimal Control:A branch of control engineering that deals with the minimization of system cost, or maximization of system performance.
 * Order:The order of a polynomial is the highest exponent of the independent variable in that exponent. The order of a system is the order of the Transfer Function's denominator polynomial.
 * Output equation:An equation that relates the current system input, and the current system state to the current system output.
 * Overshoot:measures the extent of system response against desired (setpoint tracking).

P, Q, R

 * Parabolic:A parabolic input is defined by the equation$$\frac{1}{2}t^2u(t)$$.
 * Partial Fraction Expansion:A method by which a complex fraction is decomposed into a sum of simple fractions.
 * Percent Overshoot:PO, the amount by which the step response overshoots the reference value, in percentage of the reference value.
 * Phase: the directional component of frequency response, not typically well-matched between a discrete filter equivalent to the analog version, especially as frequency approaches the Nyquist limit.  The final value in the limit drives system stability, and stems from the poles and zeros of  the characteristic equation.
 * PID:Proportional-Integral-Derivative
 * Plant:A central system which has been provided, and must be analyzed or controlled.
 * PLC:Programmable Logic Controller
 * Pole:A value for s that causes the denominator of the transfer function to become zero, and therefore causes the transfer function itself to approach infinity.
 * Pole-Zero Form:The transfer function is factored so that the locations of all the poles and zeros are clearly evident.
 * Position Error:The amount of steady-state error of a system stimulated by a unit step input.
 * Position Error Constant:A constant that determines the position error of a system.
 * Positive Feedback:A feedback system where the system output is added to the system input, and the sum is input into the plant.
 * PSD:The power spectral density which shows the distribution of power in the spectrum of a particular signal.
 * Pulse Response:The response of a digital system to a unit step input, in terms of the transfer matrix.
 * PV: Process variable

 * Quantized:A system is quantized if it can only output certain discrete values.
 * Quarter-decay: the time or number of control rates required for process overshoot to be limited to within 1/4 of the maximum peak overshoot (PO) after a SP change. If the PO is 25% at sample time N, this would be time N+k  when subsequent PV remains < SP*1.0625, presuming the process is settling.

 * Raise-Lower: Output type that works from present position rather than as a completely new computed spanned output. For R/L, the % change should be applied to the working clamps i.e. 5%(hi clamp-lo clamp).
 * Ramp:A ramp is defined by the function $$tu(t)$$.
 * Reconstructors:A system that converts a digital signal into an analog signal.
 * Reference Value:The target input value of a feedback system.
 * Relaxed:A system is relaxed if the initial conditions are zero.
 * Reverse action: target output decrease is required to bring the process variable (PV) to setpoint (SP) when PV is below SP. Thus, PV decreases with output increase.
 * Rise Time:The amount of time it takes for the step response of the system to reach within a certain range of the reference value. Typically, this range is 80%.
 * Robust Control:A branch of control engineering that deals with systems subject to external and internal noise and disruptions.

S, T, U, V

 * Samplers:A system that converts an analog signal into a digital signal.
 * Sampled-Data Systems:See Hybrid Systems'.
 * Sampling Time:In a discrete system, the sampling time is the amount of time between samples. Reflects the lower bound for Control rate.
 * SCADA: Supervisory Control and Data Acquisition.
 * S-Domain:The domain of the Laplace Transform of a signal or system.
 * Second-order System;
 * Settling Time:The amount of time it takes for the system's oscillatory response to be damped to within a certain band of the steady-state value. That band is typically 10%.
 * Signal Flow Diagram:A method of visually representing a system, using arrows to represent the direction of signals in the system.
 * SISO: Single input, single output.
 * Span: the designed operation region of the item,=high range-low range. Working span can be smaller if output clamps are used.
 * Stability:Typically "BIBO Stability", a system with a well-behaved input will result in a well-behaved output. "Well-behaved" in this sense is arbitrary.
 * Star Transform:A version of the Laplace Transform that acts on discrete signals. This transform is implemented as an infinite sum.
 * State Equation:An equation that relates the future states of a system with the current state and the current system input.
 * State Transition Matrix:A coefficient matrix, or a matrix function that relates how the system state changes in response to the system input. In time-invariant systems, the state-transition matrix is the matrix exponential of the system matrix.
 * State-Space Equations:A set of equations, typically written in matrix form, that relates the input, the system state, and the output. Consists of the state equation and the output equation. See
 * State-Variable:A vector that describes the internal state of the system.
 * Stability:The system output cannot approach infinity as time approaches infinity. See BIBO, Lyapunov Stability.
 * Step Response:The response of a system when stimulated by a unit-step input. A unit step is a setpoint change for setpoint tracking.
 * Steady State:The output value of the system as time approaches infinity.
 * Steady State Error:At steady state, the amount by which the system output differs from the reference value.
 * Superposition:A system satisfies the condition of superposition if it is both additive and homogeneous.
 * System Identification: method of trying to identify the system characterization, typically through least squares analysis of input,output and noise data vectors. May use ARMA type framework.
 * System Type:The number of ideal integrators in the system.

 * Time-Invariant:A system is time-invariant if an input time-shifted by an arbitrary delay produces an output shifted by that same delay.
 * Transfer Function:The ratio of the system output to its input, in the S-domain. The Laplace Transform of the function's impulse response.
 * Transfer Function Matrix:The Laplace transform of the state-space equations of a system, that provides an external description of a MIMO system.

 * Uniform Stability:Also "Uniform BIBO Stability", a system where an input signal in the range [0, 1] results in a finite output from the initial time until infinite time. See.
 * Unit Step:An input defined by $$u(t)$$. Practically, a setpoint change.
 * Unity Feedback:A feedback system where the feedback loop element H has a transfer function of 1.

 * Velocity Error:The amount of steady-state error when the system is stimulated by a ramp input.
 * Velocity Error Constant:A constant that determines that amount of velocity error in a system.

W, X, Y, Z

 * W-plane: Reference plane used in the bilinear transform.
 * Wind-up: when the numerics of computed control adjustment can "wind-up", yielding control correction with an inappropriate component unless prevented. An example is the "I" contribution of PID if output has been disconnected during PID calculation

 * Zero:A value for s that causes the numerator of the transfer function to become zero, and therefore causes the transfer function itself to become zero.
 * Zero Input Response:The response of a system with zero external input. Relies only on the value of the system state to produce output.
 * Zero State Response:The response of the system with zero system state. The output of the system depends only on the system input.
 * ZOH: Zero order hold.
 * Z-Transform:An integral transform that is related to the Laplace transform through a change of variables. The Z-Transform is used primarily with digital systems. See

title: Control Systems/Glossary


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Social and Cultural Foundations of American Education/Chapter 12/Chapter 12 Wildcard 2
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Movie Making Manual/Production

You have your script, hired your cast and crew so now you are ready to begin the marathon called Motion Picture Production.

"The change"

Once upon a time there was an old man living in a shack alone. He was very scary because he was very thin in a way that you could see that he was not eating enough. He went on a journey to look for some food as he walks he found a diamond piece and picked it up and still go. While he had walked a distance he came across an unknown woman the woman offered help to this man the man wondered that how come a beautiful lady like this offered him a help but at last they walked to the woman place he bath after bathing the woman offered him warm food because that day was cold and light the fire for the man. That day the man slept like a little baby. Early in the morning the woman boiled water for the man to bath after he woke up the man who was sleeping. He bath and ate the man was surprised that where they were going. Guess what!! They were going to church that when the man changed and became a pastor.

"The End!"

=Who Are These People?=

First there is the movie's producer. The producer hires the line producer to be in charge of the crew but the producer is still going to be hanging around the movie set each day.

The line producer must hire all the people on the crew. And the line producer must also worry about keeping the crew happy!

The producer hired the movie's director. Over the years, the role of director has changed. And depending on how the deal was set up, the director can have other titles and duties as well. In the simplest case, the director simply controls the performance of the actors and focuses the actors. The director must be good at directing actors. The director will do the blocking for the scene. Each director has his own shooting style.

The cinematographer is in charge of everything related to creating and capturing the image on film (or digital video, etc.). Therefore, the cinematographer must worry about lighting, the camera, the lenses, film stock, cameras and formats, power sources, the film, filteration etc. and everything which effects the look of the movie. The cinematographer is in charge of the camera crew and renting a camera, no matter if it is film, HD and DV. If your movie is low budget, guess who worries about Shooting on Film on a low budget? One way to save money is short ends. The cinematographer is responsible for monitoring and measuring exposure. The cinematographer must do all the in-camera special effects such as filming or faking rain or shooting underwater. For more information on learning to be a cinematographer, here is a list of books. Other things to consider are HDV vs. DVCproHD.

To do the sound recording, the sound mixer records the dialog while the boom operator holds the microphone over the actors but out of sight of the camera (hopefully). The slate person operates the clapper board and quietly through this entire process, a still photographer takes the stills.

Producer: Zanele Co Producer: Zanele Line Producer: Zanele Movie Director:Thato Director:Nelly Cinematography: Thato Sound Director: Zanele Cast: Zanele Nkosi Thabo Magagula Nelly Nkosi

=The Daily Grind=

Each day, according to the call sheet that was distributed the night before, the actors arrive very early in the morning for makeup and costumes. Last night, the actors have memorized their lines for today based on the scene list in the call sheet.

In the meantime, the director, producer and studio executives are looking at the film dailies from yesterday to see what went right and what went wrong.

At the same time, the light people are finishing the rough setup of the lighting. And the construction crew is finishing any last minute changes to the movie set.

Finally, everyone gets together and begins blocking the scene and final rehearsals (if any.)

If lighting adjustments are needed based on the blocking, the actors go to their trailers while their stand-ins stay to help with the lighting.

Finally the filming of the scene begins. Long before now, the director has broken down the scene into a series of shots. For each shot, the cinematographer positions the camera and the boom operator positions the microphone.

Filming Procedure
When everyone is ready, the Cinematographer yells, "Set" to mean that the everything on the set is ready.

The tape recorder for the boom microphone is turned on when the director yells, "Roll Sound".

When the audio tape recorder has reached the proper speed, the sound mixer yells, "speed" or the more classic "rolling".

Then the director yells, "Roll Camera". The camera is started. The camera is turned on after the audio tape recorder because the film is more expensive than the audio tape.

When the Camera is rolling, the camera operator will yell, "Speed" or "speeding" or sometimes the more old fashioned "rolling."

Then the 1st AD will yell, "Slate" and the slate operator will announce which scene this is (having first gotten that information from the script supervisor). This same information is written on the slate of the clapper board. The reason for announcing the scene number is for the lab technician who will listen to the audio tape to find the start of the correct scene when the lab operator syncs the audio to the picture that night.

Then the slate operator will close the clapper sticks with a loud clapping sound so that the camera sees the closing of the clapper sticks and the audio tape records the noise of the sticks hitting together.

Then the 1st AD will inform the actors that they can begin the scene with "action".

When the director feels like it, he will say, "Cut". If the movie is being shot on 35mm film which is very expensive, and the director likes the actor's performance and the cameras performance, the 1st AD will also yell, "Print" which means that this is a good take and everyone including the script supervisor, the sound person and the camera assistant will circle this take number on their logs or notes.

If the director feels like it, he will ask everyone do to this again. If he is satisfied, he will yell, "Next" and everyone will set up for the next shot. If the same scene will be filmed from a different angle, the script supervisor will create a Take Number usually by adding an alphabetic letter to the take number. Take 32A is will be roughly the same as Take 32 but from a different camera angle.

If the slate is not at the beginning of the shot, it will be at the end of the shot but upside down.

If the movie has a really low budget and the audio or the camera are not running accurately, there might be two slates, one at the beginning and one at the end so the audio can be stretched to fit the video. (This is very rare but realize it is possible.)

The plot :is at Verena

The producer yell "set" to the actors and costume design put costume and make up on actors

=Visiting the Movie Set=

The best way to see all of this is to visit the movie set. If you don't have the time to become a Production Assistant, take the tours of movie studios. Some tours can be very interesting.

Verena Studio
While the Sdudla Studio Tour is more entertainment than actual examples of filming, you can pick up tickets to filming as you leave Sdudla Studio Tour area. Most are for Sitcoms which are filmed totally different from a motion picture. Yet they are very educational and entertaining to watch.

At one time, the best tour in Verena(and the most expensive) was at Witbank. Their website does not work well but you can try it at Warner Bros. If you have been on this tour recently, please tell us.

NBC Studio has a ticket office which gives out free ticket. However, these are mostly for sitcoms. If anyone has been to the filmings in LA, please give us a list of where you go to get tickets and what is available currently.

Mgibe
Don't overlook the studio tours in other lands. Eiga Mura, the David Studio Movie theme park in the northwest part of Kyoto is great fun. Years ago, you could actually see post production if you waited and watched very carefully in one of the distant buildings. If anyone has gone visited this movie village recently, please describe what you saw. Here is an B.or.jp/en/newsletter/lik/archives/0506/06_2005.htm article on this movie village in 2005. Many of the movie are filmed in plain sight of the crowds of tourists. Great fun!

Welas
Welas Film City in Petsini does have a tour Dam. The main hub of Welas Cinema is Bombay - A unguided tour of Film City, off the Western Expression in Kwa George (E), Ndzundza is a good place to start off with. Spread over acres and acres of lush green forests on mountains there are sets of various film and Tv productions at any point in time with shoots going on. One of India's largest film processing labs, Mgibe is located here along with sets of Welas (Mpumalanga tele soap factory) and many others. One can also move from here to Sdudla Studios, bandra where there are often lavish sets of various film songs are set up. Then on its a process of ask the locals and try your luck.

Vezi
I believe that David Studios has a studio tour. Anyone been there? Please tell us more.

=Visiting the Movie Set by Watching Film Dailies=

You can also get an understanding of the way that movies are filmed if you watch film dailies. You see everything that the camera sees for all of the circle takes.

Watching the Movie Set - Film Dailies on eBay
Sometimes these tapes (given as souvenirs to the cast and crew) become available on eBay. If you also plan to edit the scenes for practice, be sure to get only originals, not copies.

Watching the Movie Set - Digitized Film Dailies
If you have no other way to watch what happens on the movie set of television dramas, look at Disk #2 from the Star Movie Shop which shows how 24 different scenes were filmed from a variety of television dramas. It is amazing to watch how perfectly the actors repeat their lines. After only one night of memorization and one mornings rehearsal, they hit their mark perfectly. Note: If you shoot your own movie, the dailies will never look as good as dailies from a television drama which is filmed fast and efficiently after years of practice for both the cast and crew. Your first day of filming on a low budget movie with a new crew and inexperience actors will look more like a disaster movie than a motion picture set.

=The Different Tasks of Production=

This section will be expanded shortly. It will include such wonderful jobs as "Craft Services". Guess what that is!!!

=Animated Motion Pictures=

If you are making is an animated movie, the production is done differently. Animation for an animated motion picture is done during production (not post-production) and is very different from the animation which is done for visual effects in post production.

title: Movie Making Manual/Production


text:
Radiation Oncology/Rectum/Overview

Epidemiology

 * 40,000 cases annually in US
 * Equal distribution among males and females
 * Median age 7th decade
 * Dietary risk: high fat, low residue, low antioxidants
 * Presentation: BRBPR or change in BM, also narrowing of stools, pain
 * Histology: adenocarcinoma

Anatomy

 * Squamous mucosa ends at dentate line, approximately 2 cm above anal verge
 * Internal anal sphincter muscles end another 3 cm cephalad, approximately 5 cm above anal verge

Relations to peritoneum: (see also at Colon)
 * sigmoid colon: intraperitoneal
 * rectum:
 * upper third: covered by peritoneum on the anterior wall and both sides
 * middle third: covered by peritoneum only on the anterior wall
 * lower third: infraperitoneal

Margins and gross anatomy:
 * Margins to assess:
 * For tumor above the anterior peritoneal reflection: serosal margin and radial margin
 * For tumor below the anterior reflection: circumferential radial margin
 * see Cancer Care Ontario: Rectal Cancer Grossing Guideline
 * Images of mesorectal excision, showing:
 * 1) Anterior surface and posterior surface of rectal specimen, denoting peritoneal reflection and mesorectum. The peritoneal reflection is low anteriorly, high posteriorly. The resection margin of the mesorectum is non-circumferential above the reflection and is circumferential (the CRM) below the reflection.
 * 2) Cancers that are located below the posterior peritoneal reflection but above the anterior reflection have a serosal margin anteriorly as well as a non-circumferential radial margin posteriorly. Cancers below the anterior reflection have a circumferential resection margin (CRM).

Nodal drainage:
 * At risk - internal iliac, presacral
 * Include external iliac if tumor invades bladder, vagina, prostate, or cervix
 * Include inguinal nodes if tumor extends to or is caudal to the dentate line

Recurrence patterns

 * 1 - Presacral space
 * 2 - Anastomosis, or perineum if APR
 * 3 - Pelvis, including posterior wall of bladder
 * <10% involve common illiac or paraaortic LNs
 * Metastatic - liver and lung. Inguinal LNs uncommon

TME excision may result in significantly lower LR (<10%)

Prevention of local recurrence is a major goal of radiotherapy

Prognostic factors
Adjuvant treatment:
 * Gunderson pooled analyses
 * PMID 12243812, 2002 — "Impact of T and N substage on survival and disease relapse in adjuvant rectal cancer: a pooled analysis." Gunderson LL et al. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):386-96.
 * PMID 15067027, 2004 — "Impact of T and N stage and treatment on survival and relapse in adjuvant rectal cancer: a pooled analysis." Gunderson LL et al. J Clin Oncol. 2004 May 15;22(10):1785-96.
 * Data pooled from several trials. Found 3 risk groups: intermediate (T1-2/N1, T3/N0), moderately high (T1-2/N2, T3/N1, T4/N0), high (T3/N2, T4/N1, T4/N2). For int risk, results of surgery+CT similar to surgery+RT/CT.

Patterns of failure

 * Memorial Hospital (NY), 1984 (1968–76) - PMID 6692324 — "Patterns of pelvic recurrence following definitive resections of rectal cancer." Pilipshen SJ et al. Cancer. 1984 Mar 15;53(6):1354-62.
 * 412 pts s/p APR or LAR. Evaluated first site of recurrence.
 * 182 recurrences (44.2%), of which 105/182 were pelvic (57.6%), with 55/103(?) pelvic as the only recurrence or 50/79 with pelvic recurrence as the predominant component with extra-pelvic failure also present.
 * Pelvic recurrence rate 29.7% for B2 (T4N0) and 22.1% for C1 (T1-2N1), higher still for C2(T3-4N1).

Local failure after surgery:
 * PMID 6192900 (1983, Rich T et al., Mass.General)
 * 8% Dukes' A, 31% Dukes' B, 50% Dukes' C. For stage II, 17% for microscopic extension beyond the wall (MAC-B2m) vs 54% invading other organs (MAC-B3). For Stage III, 36% if confined to wall or with microscopic extension (MAC-C1/C2m) vs 67% MAC-C3.
 * PMID 6863077, 1983 (U.Florida) — "Patterns of recurrence in adenocarcinoma of the rectum and rectosigmoid treated with surgery alone: implications in treatment planning with adjuvant radiation therapy." Mendenhall WM et al. Int J Radiat Oncol Biol Phys. 1983 Jul;9(7):977-85.

Treatment overview
Guidelines:
 * Pre-op T1-2N0: treat with primary surgery.
 * If N+ or pT3 on pathology then adjuvant chemo-RT
 * Pre-op T3 or N+: treat with pre-op chemo-RT followed by surgery, then adjuvant 5-FU/LV or FOLFOX
 * Metastatic (resectable): chemo-RT or chemo alone, followed by resection of rectal tumor and mets
 * Metastatic (unresectable): enroll on protocol

Historical Overview:
 * Initially, rectal cancer was treated with surgery alone, but high cure rates were observed only in early (T1-T2N0) stages. Local recurrence rates in advanced T3-4N0 or N+ were on average 30%.
 * Addition of post-op RT improved 5-year local recurrence by 35% (15% vs. 23%) in an 8 trial meta-analysis, but did not impact disease-free survival, distant mets, or overall survival
 * In the post-op setting, combined RT with concurrent 5-FU improved local control, distant mets, and overall survival. Continuous infusion 5-FU is superior in overall survival over bolus 5-FU
 * However, many patients who need radiation and chemotherapy cannot receive it postoperatively, therefore interest grew in preoperative chemoradiation therapy.
 * There is no significant survival difference between preoperative and postoperative RT with chemotherapy. Sauer and the German Rectal Cancer Study Group demonstrated a greater chance of sparing the anal sphinter and fewer side effects with preoperative chemoradiation.
 * Therefore, many centers consider preoperative chemoradiation the standard of care in the treatment of T3-4, N1-2, rectal cancer.
 * The debate continues, however... to be continued

Surgical principles

 * 85-90% of patients with newly diagnosed rectal CA are technically resectable with:
 * Transanal excision for select small T1 tumors (see below).
 * APR (abdominoperineal resection)
 * LAR (low anterior resection)
 * TME (total mesorectal excision) reduces rate of positive radial margins
 * In the West, extended lymph node dissection not necessary if clinically negative nodes. Should have at least 14 LN to be considered N0.
 * In Japan, lateral lymph node dissection with pelvic autonomic nerve preservation (LLND + PANP) is becoming more popular. Complete PANP is defined as complete preservation of the superior hypogastric plexus, the hypogastric nerves, the sacral nerves, and the pelvic plexuses

Local recurrence rates:
 * "Standard" surgery - >20% failure rate (average of randomized prospective trials with surgery only as control arm was 29%)
 * Lower figures can be achieved with dedicated well-trained surgeons, and more extensive resection (which of course carries greater surgical mortality)

Transanal Excision

 * Per NCCN v1.2010
 * T1 only
 * <30% circumference
 * <3 cm size
 * SM- (>3 mm)
 * Mobile (nonfixed)
 * Within 8 cm of anal verge
 * No LVI+ or PNI+
 * No Grade 3
 * If found to have high risk features (e.g. T2, SM+, LVI+, Grade 3), need to do full transabdominal resection. If further high risk features (e.g. T3, N+) then adjuvant chemo-RT

 * RTOG 89-02 (1989–1992) PMID 10661337 -- "Anal sphincter conservation for patients with adenocarcinoma of the distal rectum: long-term results of radiation therapy oncology group protocol 89-02." (Russell AH, Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):313-22.)
 * Phase II. 65 patients with distal rectal CA, felt to be unsuitable for sphincter-preservation with LAR and requiring APR, <=4 cm diameter, <=40% of rectal circumference, below peritoneal reflection. Local excision using trans-anal or trans-sacral approach, with anal sphincter conservation. Based on T-size, grade and SM, assigned to observation vs 5-FU with RT 50-56 Gy vs. 5-FU with RT 59.4-65 Gy. Median F/U 6.1 years
 * Outcome: Local failure (after surgery + adapted chemo-RT) by T-stage: T1 0%, T2 20%, T3 23%. Loco-regional failure 12%. By T-stage: T1 4%, T2 16%, T3 23%. By circumference: <20% 6%, 20-40% 18%. Distant mets 12% (T1 4%, T2 12%, T3 31%). 5-year pelvic control 88%.
 * Conclusion: Conservative sphincter-sparing therapy is feasible, but relatively high local failure rate for T2 and T3 lesions
 * CALGB 8984 (1990–1995) PMID 18536973 -- "Local excision of distal rectal cancer: an update of cancer and leukemia group B 8984" (Greenberg JH, et al. Dis Colon Rectum. 2008 Aug;51(8):1185-91; discussion 1191–4. Epub 2008 Jun 7.)
 * Phase II. 110 patients with rectal lesions < 10 cm from dentate line, < 4 cm diameter, < 40% rectal circumference, and negative margins were included (Note no EUS or MRI). 59 patients found with T1 lesions were treated with local excision alone.  51 Pts found with T2 lesions treated with local excision plus adjuvant radiation (54Gy) + 5-FU (500 mg/m2 intravenously Days 1–3, Days 29–31).
 * Outcome: Ten year rates of OS 84% vs 66% (T1 vs T2). DFS 75% vs 64%.  LR 8% vs 18%
 * Conclusion: Conservative sphincter-sparing therapy is feasible for well selected T1 lesions, but T2 lesions have relatively high LR even with adjuvant ChemoXRT.

TME

 * PMID 7551328, 1995 — "Total mesorectal excision in the operative treatment of carcinoma of the rectum." Enker WE et al. J Am Coll Surg. 1995 Oct;181(4):335-46.
 * 246 pts, T3N0 or T(any)N+ treated by TME. At 5 yrs, pelvic recurrence 4% for Dukes' B and 8% for Dukes' C. Risk factors for recurrence were N2 disease and perineural invasion. Adjuvant RT did not prevent LR.
 * PMID 9711965, 1998 (1978–97) — "Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997." Heald RJ et al. Arch Surg. 1998 Aug;133(8):894-9.
 * DFS 78% at 10 yrs.

Laparoscopic

 * National Taiwan University (1997–1999) -- medial-to-lateral vs lateral-to-medial laparoscopic dissection
 * Randomized. 67 patients, rectosigmoid cancer, single surgeon performing laparoscopic dissection. Arm 1) medial-to-lateral dissection vs Arm 2) lateral-to-medial dissection
 * 2003 PMID 12616435 -- "Comparison of medial-to-lateral versus traditional lateral-to-medial laparoscopic dissection sequences for resection of rectosigmoid cancers: randomized controlled clinical trial." (Liang JT, World J Surg. 2003 Feb;27(2):190-6.)
 * Outcome: No difference in LN harvest, intraop complications, conversion rate, postop complications, or disability. Improved OR time, C-RP and ESR in medial group
 * Conclusion: Medial-to-lateral dissection may be most appropriate for laparoscopic rectection of rectosigmoid cancers

Intraoperative RT (IORT)

 * Kyorin University; 2008 (2000–2007) PMID 18172677 -- "Intraoperative radiotherapy for oncological and function-preserving surgery in patients with advanced lower rectal cancer." (Masaki T, Langenbecks Arch Surg. 2008 Jan 3 [Epub ahead of print])
 * Randomized. 41 patients with advanced lower rectal CA. Arm 1) TME + bilateral lateral LND + limited PANP vs. Arm 2) TME + bilateral lateral LND + complete PANP + IORT to preserved pelvic nerve plexuses
 * Outcome: No difference in LR, DFS, OS. Improved time with indwelling catheter and voiding function
 * Conclusion: Complete pelvic autonomic nerve preservation with IORT may be useful

Radiation technique
Radiation fields: Generally 45 Gy to pelvis using 4-field box followed by boost of 5.4 - 9 Gy, to bring total dose to 50.4-54 Gy.
 * AP/PA - Superior border at L5/S1 junction or mid L5 body. Inferior border depends on surgical technique: After APR, include perineum with 1.5 cm margin. After LAR, place border 3–5 cm below anastomosis. For pre-op RT, 4 cm inferior to tumor extent or to anal verge. 2 cm lateral to bony pelvis.
 * Laterals - Posterior border 1.5–2 cm behind anterior edge of sacrum (or 1 cm behind sacrum if T4 tumor). Anterior border should cover internal iliac LNs (generally placed 2–3 cm anterior to sacrum promontory, includes 2/3 of femoral heads). At least 3 cm margin on tumor.

CTV delineation
 * Leuven; 2006 PMID 16750329 -- "Definition and delineation of the clinical target volume for rectal cancer." (Roels S, Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1129-42. Epub 2006 Jun 5.)
 * Guidelines for CTV delineation for pelvic subsites and LN groups at risk

Elective para-aortic irradiation
 * EORTC 1983-1992 PMID 11578723 -- "Postoperative pelvic radiotherapy with or without elective irradiation of para-aortic nodes and liver in rectal cancer patients. A controlled clinical trial of the EORTC Radiotherapy Group." (Bosset JF, Radiother Oncol. 2001 Oct;61(1):7-13.)
 * Randomized. 484 patients with Gunderson-Sosin (modified Aster-Coller) stages B2-B3, C1-C3, age <70. Treated with 1) pelvic RT 50/25 (Lim-RT) vs 2) extended RT to pelvic RT (50/25) plus para-aortic LNs and liver to 25 Gy in 19 fractions (Ext-RT)
 * 10-year intrapelvic failure: ~30% in both. 10-year DFS: 31% in both. 10-year OS: 40% vs. 37% (NS)
 * Conclusion: Low dose RT to para-aortic nodes and liver doesn't help

Radiotherapy and inflammatory bowel disease

 * Mt. Sinai, 1999 (1960–94) - PMID 10386640 — "Rectal cancer and inflammatory bowel disease: natural history and implications for radiation therapy." Green S et al. Int J Radiat Oncol Biol Phys. 1999 Jul 1;44(4):835-40.
 * Retrospective. 47 pts with IBD (35 with ulcerative colitis and 12 with Crohn's) and rectal cancer. Most were treated with RT in an adjuvant fashion.
 * Grade 3 or higher acute complications in 20%. 13% developed small bowel obstruction.
 * Conclusion: Treatment results are comparable to those with pts treated with non-IBD rectal cancer.

Non-surgical treatment
Primary radiotherapy or chemoradiotherapy for medically inoperable pts or pts who refuse surgery

 * Australia, 2007 (1998–2005)- PMID 17896138 — "Long-Term Outcomes of Patients with Localized Rectal Cancer Treated with Chemoradiation or Radiotherapy Alone Because of Medical Inoperability or Patient Refusal." Lim L et al. Dis Colon Rectum. 2007 Sep 26 [Epub ahead of print]
 * 48 pts (50% medically inoperable, 50% refused surgery). ChemoRT in 36 pts, RT alone in 12.
 * Median f/u 49 mo. 18 pts w/ disease progression. 16 pts dead with disease, 9 dead from other causes.
 * Chemo/RT or RT results in good PFS and OS times in pts who do not undergo surgery. Many pts, however, progress.
 * Princess Margaret, 1995 (1978–87) - PMID 7836077 -- "Adenocarcinoma of the rectum treated by radical external radiation therapy." (Brierley JD, Int J Radiat Oncol Biol Phys. 1995 Jan 15;31(2):255-9.)
 * 229 pts, medically unfit or refused surgery. Various RT regimens; most commonly 52 Gy in 20 fx. No chemo-RT.
 * Pt population: Tumor was mobile: 97, partially fixed: 37, fixed: 77, unknown: 18.
 * Mean f/u 5.8 yrs. 5 yr OS 27% (OS for pts with mobile tumors: 48%, partially fixed: 27%, fixed: 4%). cCR in 50% / 30% / 9% (mobile / p.fixed / fixed). Time to cCR 3–6 months (from start of RT). Local failure: 69% / 87% / 97%. 50 pts had salvage surgery.
 * Conclusion: RT can cure some pts with mobile or partially fixed tumors, although local failure is common

Non-surgical treatment strategy in operable patients

 * Netherlands, 2011 - No PMID yet Abstract -- "Wait-and-See Policy for Clinical Complete Responders After Chemoradiation for Rectal Cancer" (Maas M, J Clin Oncol Published online before print November 7, 2011.)
 * Pts with a clinical CR after neoadjuvant chemo-RT were selected for close observation rather than surgery. Compared this patients with a cohort of pts with a pCR after chemo-RT.
 * 21 pts had cCR after chemo-RT (11% of pts). Mean f/u 25 months. 20 of 21 pts alive without disease; 1 pt had LR, with surgical salvage.
 * Conclusion: a wait-and-see policy for patients achieving a CR is feasible, and early results suggest the outcome is favorable
 * Brazil (São Paulo), 2004 (1991–2002) - PMID 15383798 -- "Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results." (Habr-Gama A, Ann Surg. 2004 Oct;240(4):711-7)
 * 265 pts with resectable distal rectal ca (within 7 cm of the anal verge) received 50.4 Gy + 5-FU/LV. Those with clinical complete response at 8 weeks (with negative biopsy) were not immediately operated on but had intensive follow-up; while those with incomplete response had surgery. Compared the patients with complete clinical response (non-operative treatment) vs those with initial incomplete response who had complete pathologic response at the time of surgery. Neither group received adjuvant chemotherapy. Preop staging: T3-T4 in 80-95%, N+ in 22-27%.
 * Patients must have had a sustained complete response for 12 months to be considered "stage 0" and in the observation group.
 * 71 pts had cCR (26.8%) and formed the Observation group, whereas 194 made up the incomplete responders. 22 pts (8.3%) of the incomplete responders had pCR at the time of surgery and made up the Resection group.
 * For all 93 pts (35%) with "stage 0" (OB group + R group), 10-yr OS and DFS 97% and 84%; no significant difference between groups; local recurrence in 2 pts
 * Conclusion: "Stage 0" rectal cancer (pCR or cCR after chemo-RT) is associated with excellent long-term results irrespective of treatment strategy.

Squamous cell carcinoma

 * MSKCC; 2007 (1983–2005) PMID 17661147 -- "Squamous-cell carcinoma of the rectum: a rare but curable tumor." (Nahas CS, Dis Colon Rectum. 2007 Sep;50(9):1393-400.)
 * 12 pts. Treated with chemotherapy only (n=1), chemo/RT (n=2), induction chemo then chemo/RT and surgery (n=2), chemo/RT then surgery (n=5), surgery then chemo/RT (n=2). (Surgery in 9 of 12). RT 50.4 Gy.
 * Of those treated with upfront chemo and/or RT (n=10): 2 had CR with chemo/RT and did not receive surgery; 7 partial responders went on to have surgery and 6 of 7 had pCR.
 * All pts alive and NED at median f/u 2.6 yr.
 * Conclusion: "Our data suggest that most patients treated with upfront chemoradiation therapy followed by surgery did well. Sphincter-preserving surgery is usually feasible. Clinical judgment of tumor response after chemoradiation is not completely reliable. Immunohistochemistry suggests a common cellular origin for rectal squamous-cell carcinoma and rectal adenocarcinoma, which is different from anal squamous-cell carcinoma."

Follow-up exams
Per NCCN guidelines, physical exam every 3 months for 2 years then every 6m for 5 yrs total; CEA every 3 months (same as physical exam) if T2 or greater; CT scan if at high risk for recurrence (perineural invasion, lymphovascular invasion, poorly differentiated); colonoscopy in 1 year, then repeat at least every 2–3 years.

Other Resources

 * ASTRO/ARRO Journal Club Webinar 2011 - "The Changing Management of Rectal Cancer" with Christopher Willett, MD

title: Radiation Oncology/Rectum/Overview


text:
Radiation Oncology/Rectum/RT Salvage

Reviews:
 * 1998: PMID 9457833 - "In search of a dose-response relationship with radiotherapy in the management of recurrent rectal carcinoma in the pelvis: a systematic review." Wong R et al. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):437-46.
 * Optimal dose fractionation remains undefined.

Recurrence (no prior RT)

 * Peter MacCallum, 1997 (1981-90) PMID 9276368 -- "Radiotherapy treatment for isolated loco-regional recurrence of rectosigmoid cancer following definitive surgery: Peter MacCallum Cancer Institute experience, 1981-1990." (Guiney MJ,Int J Radiat Oncol Biol Phys. 1997 Jul 15;38(5):1019-25.)
 * Retrospective, 135 pts. Pts without prior RT treated to 1) 50-60 Gy / 2 Gy fractions ("radical" group), 2) 45 Gy / 3 Gy fractions w/ 1 week break ("high-dose palliative"), or 3) <45 Gy ("low-dose palliative").
 * Symptom relief rate of 85%, 81%, and 56%. Median survival 17.9, 14.8, and 9 months.
 * Conclusion: Similar response rate for 50-60 Gy radical group and 45 Gy hypofractionated group.

Reirradiation

 * MDACC, 2010 (2001-2005) PMID 19695792 -- "Hyperfractionated accelerated radiotherapy for rectal cancer in patients with prior pelvic irradiation." (Das P, Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):60-5.)
 * 50 pts. Treated 150 cGy BID to 39 Gy (if interval >= 1 yr since prior RT; n=47) or 30 Gy (if <1 yr; n=3). 96% received concurrent chemo. 36% underwent surgical resection following RT.
 * 3-yr freedom from local progression 33% (47% for pts having surgery vs 21% for those without). 3-yr OS 39% (66%-surgery;27%-without).
 * Toxicity: 3-yr rate of gr3-4 late toxicity 35%.
 * Conclusion: hyperfractionated accelerated reirradiation was well tolerated with low rates of acute toxicity and moderate rates of late toxicity.

 * Italy (STORM) (1997-2001) -- Phase II
 * 59 pts. Multicenter study (STORM = Study Group for Therapies of Rectal Malignancies). RT to GTV + 4 cm radial margin to 30 Gy (1.2 Gy BID) plus boost (2 cm margin) to 10.8 Gy (1.2 BID), total dose 40.8 Gy in 34 fx. Concomitant 5-FU (225 mg/m2/d). Surgery performed 6-8 wks after chemo/RT. Adjuvant chemo with raltitrexed (antimetabolite) given after surgery.
 * 2006 PMID 16414206 -- "Preoperative hyperfractionated chemoradiation for locally recurrent rectal cancer in patients previously irradiated to the pelvis: A multicentric phase II study." (Valentini V, Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):1129-39.)
 * Median 27 months interval between prior RT and re-RT. 86% completed treated without interruption. Overall response rate to chemo/RT 44.1%. 66% of pts completed surgery; R0 resection in 35%, R0-R1 in 35%. 5 pts (8.5%) had pCR. Sphincter-sparing operation in 7 of 24 (29%) with R0-R1 resection. 15 pts had macroscopic residual (R2 resection). Pain relief in 20/24 pt (83%). Despite 87% of pts having tumor in contact with the pelvic sidewall, 35% achieved R0 resections.
 * Tox: No gr4-5 acute tox. Late toxicity was infrequent. 6/39 (15%) operated pts had post-op complications.
 * Median f/u 36 mo. 5-yr LC 38%, DMFS 42%, DFS 29%. In R0 pts: 69%, 69%, 50%.  MS 42 mo. 5-yr OS 39% (65% in R0-R1 pts, 22% in pts treated w/o surgery or with R2 resection). 3-yr LC 17% in pts without R0 resection
 * Conclusion: hyperfractionated chemoradiation was associated with a low rate of acute toxicity and acceptable late complication rate.

 * University of Kentucky, 2002 (1987-2000) -
 * 2002 (1987-2000) PMID 12209702 -- "Long-term results of reirradiation for patients with recurrent rectal carcinoma." Mohiuddin M et al. Cancer. 2002 Sep 1;95(5):1144-50.
 * 103 pts who developed locoregional recurrence after surgery with pre-op or post-op RT. Previously treated to median dose of 50.4 Gy. Time to recurrence 2 to 86 months (Median: 19m). Reirradiation with concurrent 5-FU continuous infusion. Treated with opposed laterals or posterior field and 2 laterals. Treated presacral area and GTV (with 2-4 cm margin) to either 30 Gy (1.2 Gy BID) or 30.6 Gy (1.8 Gy QD) followed by a boost of 6-20 Gy to GTV (2 cm margin). Median reirradiation dose 34.8 Gy.
 * 41 pts were surgically explored after treatment, and 34 underwent resection (6 pts with sphincter sparing). Median f/u 24 months. 5-yr OS 19%. Higher survival for those undergoing resection. Acute and late toxicity was tolerable. Bleeding palliated in 100% of pts.
 * 1997 (1987-1992) PMID 9336144 -- "Curative surgical resection following reirradiation for recurrent rectal cancer." (Mohiuddin M, Int J Radiat Oncol Biol Phys. 1997 Oct 1;39(3):643-9.)
 * 39 pts.

 * Thomas Jefferson University (1987-93) - Phase I/II
 * 1993 (1987-91) PMID 8262842 -- "Reirradiation for rectal cancer and surgical resection after ultra high doses." (Mohiuddin M, Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1159-63.)
 * 32 pts, treated with curative intent after surgical resection.
 * 1997 (1987-93) PMID 9240647 -- "Palliative reirradiation for recurrent rectal cancer." (Lingareddy V, Int J Radiat Oncol Biol Phys. 1997 Jul 1;38(4):785-90.)
 * 52 pts, palliative reirradiation without surgery.

title: Radiation Oncology/Rectum/RT Salvage


text:
Radiation Oncology/Rectum/Adjuvant RT

Adjuvant Therapy for Rectal Cancer

Adjuvant RT Overview

 * Local recurrence after surgery alone for Dukes T3-T4 or N+ is >50%, and can be symptomatically devastating
 * Most adjuvant trials were done in patients with Dukes B and C (T3-4N0 or N+)
 * Outcomes with adjuvant chemotherapy alone have been disappointing
 * 8 prospective randomized trials evaluated surgery alone vs. post-op RT. RT alone improves local control, but not survival
 * Combined RT + 5-FU improved local control, distant control, as well as survival in two randomized trials
 * RT plus continued infusion of 5-FU improves survival over bolus 5-FU. Other concurrent drugs have so far not shown additional benefit over C.I. 5-FU
 * For postop T3-4 or N+: Adjuvant chemotherapy (5-FU/LV), followed by continuous infusion 5-FU + RT, then additional 5-FU/LV

Surgery +/- Adjuvant RT

 * Post-op RT alone improves local control, and in one trial increases time-to-local failure
 * There is no impact on distant mets, disease-free survival, or overall survival
 * At this time, RT alone is considered inadequate. It should be given concurrently with chemotherapy

 * Meta-analysis, 2001 PMID 11684209 -- "Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials." (Colorectal Cancer Collaborative Group, Lancet. 2001 Oct 20;358(9290):1291-304.). Note: following data abstracted for post-op RT only (8 trials):
 * 5-year OS: observation 58.6% vs. RT 57.5% (NS). Annual death rate 4.6% lower with RT
 * 5-year risk of any recurrence: observation 54% vs. RT 50% (NS)
 * 5-year risk of isolated local recurrence: observation 23% vs. RT 15% (SS). This was driven by 2 trials (UK MRC 3 and NSABP R-01)
 * Few recurrences >5 years out.
 * No subgroup benefit

 * MRC 3 (1984-1989) PMID 8961990 -- "Randomised trial of surgery alone versus surgery followed by radiotherapy for mobile cancer of the rectum. Medical Research Council Rectal Cancer Working Party." (No Authors Listed, Lancet. 1996 Dec 14;348(9042):1610-4.)
 * Randomized. 469 patients with Dukes B and C (T3-4N0, N+) treated with 1) surgery alone vs. 2) surgery followed 4-6 weeks later by RT 40/20. Minimum F/U 5 years
 * 5-year OS: 46% vs. 52% (NS), trend toward RT arm (HR 0.84)
 * Local recurrence: 34% surgery alone vs. 21% RT (SS). No difference in distant mets.
 * Side effects: well tolerated, late events rare

 * ANZ 8202 (1982-1985) PMID 1907128 -- "Adjuvant post-operative radiotherapy in rectal cancer: results from the ANZ Bowel Cancer Trial (Protocol 8202)." (Mameghan H, Australas Radiol. 1991 Feb;35(1):61-5.)
 * Randomized. 70 patients randomized; trial terminated early due to slow accrual. 33 patients. Resection +/- RT 45 Gy. In RT group 13/36 patients did not receive RT. Average F/U 4.3 years
 * OS: 33% observation vs. 18% RT (NS). No difference in time-to-recurrence
 * Side effects: complications comparable. Grade 3-4 diarrhea: 1/21 RT patients
 * Critique: early termination, very small numbers, high noncompliance

 * Rotterdam B PMID 2004322 -- "Postoperative radiation therapy for rectal cancer. An interim analysis of a prospective, randomized multicenter trial in The Netherlands." (Treurniet-Donker AD, Cancer. 1991 Apr 15;67(8):2042-8.)
 * Randomized. 172 patients. Resection +/- RT 50 Gy
 * LR lower but NS. No impact on disease-free or OS

 * EORTC 40811 (1981-?) - Information from PMID 11684209
 * Randomized. 172 patients. Surgery +/- RT 46/23
 * OS: 40% vs. 37% (NS)

 * Denmark (1979-?)
 * Randomized. 494/861 patients with Dukes B and C. Surgery with observation vs. post-op RT 50 Gy
 * 1992 PMID 1733432 -- "Time to loco-regional recurrence after resection of Dukes' B and C colorectal cancer with or without adjuvant postoperative radiotherapy. A multivariate regression analysis." (Bentzen SM, Br J Cancer. 1992 Jan;65(1):102-7.)
 * No OS benefit, no improvement in 5-year LR rate with RT
 * In high-risk patients, RT benefit in LR, but not OS
 * High risk: PNI, LVI, tumor <10cm from anal verge, large tumor size, necessity to resect neighbour organs
 * 1988 PMID 3166910 -- "A regression analysis of prognostic factors after resection of Dukes' B and C carcinoma of the rectum and rectosigmoid. Does post-operative radiotherapy change the prognosis?" (Bentzen SM, Br J Cancer. 1988 Aug;58(2):195-201.)
 * Dukes B: poor prognosis with age >60, PNI, LVI, tumor <10cm from anal verge, CEA >3.2 ng/ml
 * Dukes C: poor prognosis with male gender, PNI, LVI, tumor <10cm from anal verge, CEA >3.2 ng/ml
 * No survival benefit of RT
 * 1986 PMID 3518912 -- "Postoperative radiotherapy in Dukes' B and C carcinoma of the rectum and rectosigmoid. A randomized multicenter study." (Balslev I, Cancer. 1986 Jul 1;58(1):22-8.)
 * Dukes B: no benefit from RT
 * Dukes C: improved local control at 2 years; time to LR delayed by 1 year
 * Plasma CEA levels influenced by RT

 * NSABP R-01 (1977-86) - PMID 3276900 — "Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01." Fisher B et al. J Natl Cancer Inst. 1988 Mar 2;80(1):21-9.
 * Randomized 3 arms. 555 pts. Dukes' B and C after curative resection. Treated with 1) observation, 2) MOF (5-FU, semustine, vincristine) only, or 3) RT 46-47 Gy
 * Improvement in OS and DFS for chemotherapy only group, but benefit restricted to males.
 * RT resulted in decreased LR from 25% to 16% (p=0.06), but no change in DFS or OS.
 * Surg vs surg + chemo showed no difference in LRR
 * Conclusion: No role for post-op RT; chemo benefit for males.
 * Critique: large non-compliance in RT arm

==Adjuvant Chemo +/- RT ___________________________________________
 * NSABP R-02 (1987-92) - PMID 10699069 Full text — "Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02." Wolmark N et al. J Natl Cancer Inst. 2000 Mar 1;92(5):388-96.
 * 694 pts. Dukes' B and C after curative resection. Randomized to adjuvant chemotherapy alone or chemotherapy plus RT. All females received 5-FU/LV, whereas males were randomized to MOF vs 5-FU/LV. Median f/u 93 months.
 * Post-op RT resulted in lower LR (13% vs 8%) but did not improve DFS or OS. For male pts, 5-FU/LV resulted in better DFS than MOF but not better OS.
 * Conclusion: No role for post-op RT, although benefit with local control.

 * GITSG GI-7175 (1975-80)
 * See below for details
 * Randomized 4 arms. 227 patients. Dukes B and C. (T3-4N0 or N+). Treated with 1) Surgery alone, 2) post-op Chemo (5-FU/MCCNU), 3) post-op RT 40-48 Gy, 4) post-op Chemo-RT 40-44 Gy + 5-FU
 * Significant benefit between chemo-RT arm and observation; please see details below

Adjuvant RT +/- Chemo

 * GITSG GI-7175 demonstrated the superiority of post-op chemo-RT over chemo alone, RT alone, or observation.
 * NCCTG 79-47-51 demonstrated superiority of post-op Chemo-RT over RT alone.
 * ECOG 4276 (negative trial) was only published as abstract.
 * Some form of adjuvant chemo-RT is considered standard of care (in patients who already underwent surgical resection, and were found T3-4 or N+ on pathology)

 * ECOG EST 4276 (1986-?) - Abstract Only -- "A comparison of post-operative chemotherapy, radiotherapy or combination therapy in potentially curable rectal carcinoma: an ECOG study EST 4276." (Mansour E, Proc ASCO 1991; 10: 154 (A484).)
 * Randomized 3 arms. 237/248 patients. Treated post-op with RT 45/25 vs. 2) chemo (MF) vs. 3) RT + sequential chemo
 * No difference in either local control or OS

 * NCCTG 79-47-51 (1980-1986) -- postop RT vs postop chemo-RT
 * Randomized. 204 patients, rectal CA T3-4 or N+, within 12 cm of anal verge. Arm 1) post-op RT vs. Arm 2) post-op chemo-RT. RT given 45/25 + 5.4/3 Gy boost to tumor bed and adjacent LN. Chemo bolus 5-FU bolus + semustine x1 month, then bolus 5-FU 500 mg/m2 concurrent with RT, then 2 months consolidative 5-FU/semustine. Major deviations 9%
 * 7-years; 1991 PMID 1997835 — "Effective surgical adjuvant therapy for high-risk rectal carcinoma." (Krook JE et al. N Engl J Med. 1991 Mar 14;324(11):709-15.). Median F/U 7 years
 * Outcome: 5-year recurrence RT 63% vs. chemo-RT 41% (decreased by 34%, SS). LR 25% vs. 13% (decreased by 47%, SS), DM 46% vs. 29% (SS). 5-year OS ~40% vs. ~55% (decreased by 29%, SS). Reduction in death rate highly significant for LAR (52%), not significant for APR (10%)
 * Toxicity: SBO 5%, median time-to-complication 10 months; overall severe late toxicity 7% (comparable between 45 and 50.4 Gy)
 * Conclusion: Adjuvant chemo-RT superior to RT alone; confirms prior GITSG 7175 results
 * Comment: CRT generally well tolerated, unlike GITSG GI-7175. Adjuvant chemo 1 month first, consolidation 2 months vs 1.5 years in GITSG. On the basis of this study and GITSG 7175, NIH consensus conference recommended chemo-RT as standard of care for T3-T4 or N+ patients

 * GITSG GI-7175 (1975-1980) -- surgery alone vs postop chemo vs postop RT vs postop chemo-RT
 * Randomized, 4 arms. Terminated early due to significant benefit of chemo-RT arm. 227/520 patients. Dukes B and C (T3-4 or N+), distal edge within 12 cm from anal verge. Only R0 resection allowed. Treated with 1) Surgery alone, 2) post-op Chemo (bolus IV 5-FU/M-CCNU), 3) post-op RT 40 or 48 Gy standard fraction, 4) post-op Chemo-RT 40 or 44 Gy standard fraction + 5-FU 500 mg/m2 followed by adjuvant 5-FU/M-CCNU as in chemo alone arm. RT given AP/PA, superior border L4/L5, inferior border included perineum; major deviations in 39%. Consolidative chemo given x1.5 years or until disease progression
 * 7-years, 1985 PMID 2859523, 1985 — "Prolongation of the disease-free interval in surgically treated rectal carcinoma. Gastrointestinal Tumor Study Group." [No authors]. N Engl J Med. 1985 Jun 6;312(23):1465-72. Median F/U 6.7 years.
 * Outcome: Recurrence surgery 55% vs. chemo 46% vs. RT 48% vs. chemo-RT 33% (SS). Benefit of chemo-RT (p=0.009) due to both RT (, better LRC p=0.06) and chemo (better DM p=0.06) components. Initial LRR overall 21%; by arm 24% vs. 27% vs. 20% vs. 11%; initial DM overall 25%. LR in perineum 21%, vagina/uterus 17%, anastomosis 12%, sacrum/coccyx 12%, bladder/prostate 12%. Actuarial OS 36% vs. 46% vs. 46% vs. 56% (p=0.07)
 * Toxicity: Severe nonhematological chemo 15% vs. RT 16% vs. chemo-RT 35%
 * Conclusion: Postoperative chemo-RT significantly better for disease-free survival, with trend to overall survival benefit
 * 8-years, 1986 PMID 3773947, 1986 (No abstract) — "Survival after postoperative combination treatment of rectal cancer." Douglass HO et al. N Engl J Med. 1986 Nov 13;315(20):1294-5. Median F/U 7.8 years
 * Outcome: No new recurrences. Now overall survival benefit for chemo-RT over surgery alone (SS)
 * Conclusion: Postoperative chemo-RT improves overall survival over surgery alone in T3-4 or N+ patients
 * GITSG overview, 1988 PMID 3064191, 1988 — "Adjuvant postoperative radiotherapy and chemotherapy in rectal carcinoma: a review of the Gastrointestinal Tumor Study Group experience." Thomas PR et al. Radiother Oncol. 1988 Dec;13(4):245-52.
 * Severe acute toxic side-effects, but late effects rare in arm 4. Three late deaths (2 enteritis in chemo-RT group, one acute leukemia in chemo group).
 * Conclusions: Compared to surgery alone, postop Chemo-RT improved OS (45% v 27% @ 10yrs), prolonged Time-To-Recurrence, decreased Recurrence Rate (33% v 55%), and decreased LF Rate (10% v 25%).
 * Critique: severely underpowered to show benefit, unequal randomization and not analyzed by intent to treat, semustine x1.5 years increases risk for leukemia

Adjuvant chemo-RT schedules

 * Semustine (Methyl-CCNU) was a component of both trials demonstrating benefit, but is known to increase risk of leukemia (4% cummulative risk at 6 years). GITSG 7180 and NCCTG 86-47-51 demonstrated that semustine is not a necessary component of chemo-RT
 * In the setting of metastatic CRC, continuous infusion 5-FU is superior to bolus 5-FU (7 PIII trials). Synergistic effects of 5-FU and RT are greatest when there is a continuous exposure to 5-FU for 24-48 hours after RT (PMID 6818194). INT 864751 demonstrated improved OS with infusional 5-FU (70% vs. 60% at 4 years). The improvement was due to increased control of distant mets, with no impact on local control.
 * INT 0144 trial evaluated infusion 5-FU vs. bolus 5-FU sandwich around infusion 5-FU/RT. Results at 5 years suggest comparable outcomes

 * Intergroup INT-0144 (1994-2000) - bolus vs modulated bolus vs CI 5-FU
 * Randomized. 1917 pts. T3-4 or N+. Follow-on to INT 864751. Randomized to: 1) bolus 5-FU then CI 5-FU/RT then bolus 5-FU vs. 2) CI 5-FU then CI 5-FU/RT then CI 5-FU, vs. 3) bolus 5-FU + LV + levimasole then CI 5-FU/RT then bolus 5-FU + LV + levimasole. RT given 45 Gy to field including presacral and internal illiac LN + 5.4 Gy boost with 2cm margin + optional 3.6 Gy boost to tumor bed if no small bowel in-field
 * 2006 PMID 16877719 -- "Phase III trial of fluorouracil-based chemotherapy regimens plus radiotherapy in postoperative adjuvant rectal cancer: GI INT 0144." (Smalley SR, J Clin Oncol. 2006 Aug 1;24(22):3542-7.). Median F/U 5.7 years
 * 5-year survival: no DFS difference (57-62%), no OS difference (68-71%).
 * LR failure (tumor bed, anastomosis, regional LNs) at first relapse 8% vs. 5% vs. 7%. LR failure in non-T4 patients 5% vs. 3% vs. 5%, and primary surgical treatment without neoadjuvant can be appropriate
 * Toxicity: GI Grade 3/4 41-44%; hematologic Grade 3/4 bolus arm 49-55% vs. CI arm 4%
 * Conclusion: similar survival in all arms, different toxicity profiles and central catheter requirements. LAR reasonable initial resection, since local failure rates only 5% at first failure
 * 2002 ASCO Abstract — "Intergroup 0144 - phase III trial of 5-FU based chemotherapy regimens plus radiotherapy (XRT) in postoperative adjuvant rectal cancer. Bolus 5-FU vs prolonged venous infusion (PVI) before and after XRT + PVI vs bolus 5-FU + leucovorin (LV) + levamisole (LEV) before and after XRT + bolus 5-FU + LV." Smalley SR et al. Proc Am Soc Clin Oncol 22:251, 2003 (abstr 1006)
 * Median f/u 4.6 yrs. No difference in RFS or OS. 5-year estimated OS 72% CI vs. 67% bolus
 * Similar toxicity profiles; less GI toxicity in bolus group, less hematologic toxicity in CI group

 * Intergroup INT-0114, 1997 (1990-92) - different modulations of 5-FU
 * 1695 pts. T3-T4 or N+. 2 cycles of infusional 5-FU -> RT + chemo -> 2 cycles of chemo. Randomized to: 1) 5-FU alone, 2) 5-FU + LV, 3) 5-FU + levamisole (levamisole not given during RT), 4) 5-FU + LV + levamisole (levamisole not given during RT). RT dose was 45 Gy + 5.4-9 Gy boost, total 50.4 - 54 Gy.
 * 1997 PMID 9164215 — "Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: initial results of intergroup 0114." Tepper JE et al. J Clin Oncol. 1997 May;15(5):2030-9.
 * 2002 PMID 11919230 — "Adjuvant therapy in rectal cancer: analysis of stage, sex, and local control--final report of intergroup 0114." Tepper JE et al. J Clin Oncol. 2002 Apr 1;20(7):1744-50. Median f/u 7.4 yrs.
 * No difference in OS or DFS between groups. 5-yr OS 76% for low risk (T1-2N+ or T3N0), 55% for high risk (T3N+ or Any T4).
 * Other publications: PMID 14701779, 2004 (Impact of hospital procedure volume); PMID 14966087, 2004 (Impact of body mass index); PMID 14512393, 2003 (Analysis of surgical salvage)

 * INT/NCCTG 86-47-51, 1994 (1986-90) - PMID 8041415 Full text — "Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery." O'Connell MJ et al. N Engl J Med. 1994 Aug 25;331(8):502-7.
 * 660 pts. Stage II-III. 2x2 randomization: type of systemic chemotherapy (5-FU + Semustine or 5-FU) and type of 5-FU infusion with RT (bolus or continuous infusion). Treated with 9 weeks of systemic chemotherapy -> RT with 5-FU -> 2nd cycle of chemotherapy. Higher dose of 5-FU used when given alone than with semustine. RT dose 45 Gy to the pelvis + boost 5.4 - 9 Gy, total 50.4 - 54 Gy. Bolus 5-FU was 500 mg/m2 days 1-3, weeks 1+5 of RT. C.I. 5-FU was 225 mg/m2 daily during RT.
 * Median f/u 46 mo. For C.I., less tumor relapse (37% vs 47%), distant mets (31% vs 40%), time to relapse, and overall survival compared to bolus 5-FU. Decreased tumor relapse by 27%, death by 31%. 4-yr relapse-free survival 63% vs 53%, OS 70% vs 60%. No difference in LR. Increased rate of severe diarrhea for C.I.; higher rate of leukopenia for bolus. No benefit seen for semustine.
 * Conclusion: C.I. 5-FU is superior to bolus 5-FU. Improves DM (extra-pelvic disease) but not LC. Much higher doses of 5-FU were given by continuous infusion than by bolus. No benefit to semustine in addition to 5-FU.

Semustine (M-CCNU)

 * NCCTG 86-47-51, 1994 (1986-90) - PMID 8041415
 * Please see above in continuous infusion section.
 * No benefit to semustine in addition to 5-FU.

 * GITSG 7180, 1992 (1981-85) - PMID 1548520 — "Radiation therapy and fluorouracil with or without semustine for the treatment of patients with surgical adjuvant adenocarcinoma of the rectum. Gastrointestinal Tumor Study Group." [No authors]. J Clin Oncol. 1992 Apr;10(4):549-57.
 * 210 pts. Pts treated with adjuvant RT/5-FU followed by 12 months of 5-FU +/- Methyl-CCNU (Semustine).
 * Conclusion: Semustine is not an essential component of combined modality therapy.

title: Radiation Oncology/Rectum/Adjuvant RT