NRG PROTOCOL RADIATION THERAPY TEMPLATE

DISEASE SITE: Lower Gastro-Intestinal Cancer

SUB-COMPONENT: Rectal Cancer

Authors & Affiliations:

___ William Parker, McGill University, Montreal, Quebec, Canada
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Reviewers &Affiliations:
Ying Xiao, Ph.D., University of Pennsylvania, Philadelphia, PA______________
Tim Ritter, --------
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______________________________________________________________________

Maintained By: NRG Medical Physics Subcommittee

NRG Radiation Oncology Committee

Last Updated: 11-1-2016

 Underlined highlighted texts are either instructions or suggestions to be deleted or replaced by PIs
5.2 Radiation
with regular textsTherapy
without highlight.
Notes 1,2,…:
A rectal The
cancer note(s)
case includedasatan
is presented this point inonly.
example the protocol should be designed to emphasize
special information that the study chair does not want the investigator to overlook. An example might
beRegular
a statement that IGRT
highlighted textsisare
required for the
examples study.
to be selected (remove highlight), deleted or replaced by PIs
with
This regular
protocol texts.
allows, but does not require, the use of Intensity Modulated Radiation Therapy (IMRT). Institutions using
IMRT must be credentialed for IMRT for the modality chosen for treatment as specified by IROC Houston (Section xx).
IGRT credentialing is not required; however, a facility questionnaire must be completed. Credentialing requirements can
be found in Section xx.

Radiation Therapy Schema

The treatment is delivered in 2 phases: an initial phase treating the entire PTV_4500 (including the PTV_5040 volume) to
45 Gy, followed by a boost phase treating the PTV_5040 with an additional 5.4 Gy, for a total dose of 50.4 Gy. The
fraction size is 1.8 Gy for all phases. A concomitant can boost may be considered whereby the initial and boost treatments
are delivered simultaneously.

5.2.1 Treatment Technology

List allowed Treatment Modalities (including energy): photons, electron, brachytherapy, …..
Required Capabilities: IMRT, IGRT, etc.

This protocol requires treatment with photons with a minimum nominal energy specification of 6 MV. IMRT is allowed
and can be used either with static gantry or arcs (VMAT). Tomotherapy delivery is allowed.

5.2.2 Immobilization and Simulation

Proper immobilization is important for this protocol. Patient setup reproducibility must be achieved using appropriate
clinical devices. A custom immobilization device (using foaming resins that become rigid, vacuum forms, and/or possibly
a belly board providing bowel displacement for prone patients) is suggested to minimize set-up variability. Simulation may
be done with the patient in the supine or prone position.
Simulation Imaging

This subsection should include information about the extent of CT imaging, the resolution of the scan
information including the slice thickness, and details of the allowed use of contrast agents and the
handling of tissue densities when contrast is used.

CT Simulation is required and the images must be acquired using a CT-simulator with a slice
thickness ≤ 3 mm. Care should be taken to use the smallest possible FOV that contains the entire
surface of the patient within a 512x512 or larger image matrix. Oral CT contrast is strongly suggested.
An anal marker at the verge is recommended. The CT simulation must be performed with the patient
in the treatment position the use of IV contrast is allowed to aid in target definition.
The use of MRI for simulation is permitted, the dataset used for the dose calculations must be
submitted.
Follow institutional guidelines for scan limits, typical CT scan limits are mid-femur inferiorly to
include the L2 vertebral body superiorly or more up to T9 if para-aortic nodes need to be treated . The
CT scan must include structures specified in 5.2.4 and 5.2.5, with at least a 2 cm margin beyond
superiorly and inferiorly of any delineated structure or target.

5.2.3 Imaging for Structure Definition, Image Registration/Fusion and Follow-up

Please remove this subsection if it does not apply to your protocol.

FDG-PET/CT imaging may be obtained as part of staging and radiation planning, in or to assist in
volume delineation in all eligible patients.
5.2.4 Definition of Target Volumes and Margins
Note: All structures must be named for digital RT data submission as listed in the table below. The
structures marked as “Required” in the table must be contoured and submitted with the treatment plan.
Structures marked as “Required when applicable” must be contoured and submitted when applicable.
Resubmission of data may be required if labeling of structures does not conform to the standard
DICOM name listed. Capital letters, spacing and use of underscores must be applied exactly as
indicated.
The volumes are to be defined by planning CT/MRI techniques as well as PET scans when clinically
appropriate. While PET scans are not mandated as part of the protocol, for those patients who have
PET scans available, the information may be used to aid in treatment planning. The inferior extent of
palpable tumors should be determined by physical examination.
Examples of contoured patients (anorectal atlas) are available for review on the NRG Oncology
website (https://www.nrgoncology.org/Resources/Contouring-Atlases). These examples are excellent
resources for the contouring of normal structures as well as GTV, CTV and PTV design, and their use
is strongly encouraged.

Entries in the first column of the list below will be entered and edited by the QA Staff. The PIs are
required to specify the information in the second, third columns. The detailed specifications have to
include crucial items such as boundary definitions and margins.

Standard Validation Required/Required

Description
Name when applicable/Optional

GTV_5040 GTV to receive 50.4 Gy Required

CTV_5040 CTV to receive 50.4 Gy Required

PTV_5040 PTV to receive 50.4 Gy Required

GTV_4500 GTV to receive 45 Gy Required

CTV_4500 CTV to receive 45 Gy Required

PTV_4500 PTV to receive 45 Gy Required

Detailed Specifications

Gross tumor volume (GTV_5040): This includes the primary tumor and any pelvic nodes felt involved
grossly with metastatic disease. Assessment of the primary tumor and nodal disease may be made on
the basis of endoscopy, CT, PET-CT, MRI, or EUS (endoscopic ultrasound) transrectal
ultrasonography. The entire rectal circumference at the level of the tumor should be included as
GTV_5040.

Clinical target volume (CTV_5040): is an expansion of the GTV_5040 by 2 cm (protocol PI’s

discretion).

Planning Target Volume (PTV_5040): is an expansion of the CTV_5040 by 0.5 – 1.0 cm (protocol PI’s
discretion) depending on the type of IGRT used, smaller margins are not allowed.

Gross tumor volume (GTV_4500): This includes the primary tumor and any pelvic nodes felt involved
grossly with metastatic disease. Assessment of the primary tumor and nodal disease may be made on
the basis of endoscopy, CT, PET-CT, MRI, or EUS (endoscopic ultrasound) transrectal
ultrasonography. The entire rectal circumference at the level of the tumor should be included as
GTV_4500 if it is a rectal cancer.

Clinical target volume (CTV_4500): This includes the GTV_4500 and the following nodal groups:
perirectal nodes (entire mesorectum) ; presacral nodes; internal iliac; external iliac when indicated and
common iliac nodes up to L4-L5junction.

The CTV_4500 can be formed from the following CTV sub-volumes:

CTV_rectal = Rectal GTV +1.5 cm radially, +2.5 cm (protocol PI’s discretion) craniocaudally along
the mucosal surface. The radial expansion can be shrunk to within the mesorectal fascia and off
organs/sidewall if there is no clinical/radiographic evidence of an involved mesorectal fascia OR T4
disease.

CTV_nodal = Nodal GTV + 1.5cm symmetrical expansion (protocol PI’s discretion). The symmetric
expansion can be shrunk to within the mesorectal fascia and off organs/sidewall if there is no
clinical/radiographic evidence of an involved mesorectal fascia.

CTV_vessels = Uninvolved iliac vessels + .7 - 1.0 cm (protocol PI’s deiscretion). This expansion can
be trimmed off pelvic sidewall/bowel.

CTV_presacral = the entire sacral hollow from mid S1-S5 and 8 mm tissue anterior to the anterior
border of the sacral bone (protocol PI’s discretion).

CTV_perirectal = The mesorectum and perirectal lymphatic CTV should be identified on cross-
sectional imaging and is best seen on an MRI. If the fascia cannot be confidently visualized, it can be
generated by utilizing the following anatomic landmarks:

Posterior Border: anterior border of the sacrum and gluteus maximus

Lateral Border: ileum, piriformis and obturator muscles

Anterior Border: should include the interface with the bladder, vagina, uterus or prostate
Inferior Border: the levators

Planning target volume (PTV_4500): This will provide a margin around the CTV_4500 to compensate
for the inter- and intra-fraction uncertainty consequent to daily setup uncertainty and to potential
internal organ motion. By definition, the PTV_4500 will consist of a symmetrical
variable expansion 5-15 mm expansion around the CTV_4500 depending on the institution’s IGRT
technique. In the event that a PTV_4500 extends outside of the skin surface, a modifiedPTV to be
used for dose reporting and planning should be created by cropping the PTV_4500 contours to be 3
mm inside the outer skin (unless there is direct skin involvement).

5.2.5 Definition of Critical Structures and Margins

Note: All structures must be named for digital RT data submission as listed in the table below.
The structures marked as “Required” in the table must be contoured and submitted with the
treatment plan. Structures marked as “Required when applicable” must be contoured and
submitted when applicable.
Resubmission of data may be required if labeling of structures does not conform to the
standard DICOM name listed. Capital letters, spacing and use of underscores must be applied
exactly as indicated.

Entries in the first column of the list below will be entered and edited by the QA Staff. The PIs are
required to specify the information in the second, third columns.The detailed specifications have to
include crucial items such as boundary definitions and margins.

Validation
Standard Name Description Required/Required when
applicable/Optional

Bladder Bladder Required

Femur_Head_R Right femur head Required

Femur_Head_L Left femur head Required

Bowel_Small Small Bowel Required

All tissue excluding

E-PTVs Required
all PTVs.

Detailed Specifications

Small Bowel:
The small and large bowel are important structures to consider when planning treatment. To avoid
unnecessary time spent contouring the entire abdominal contents, they only need to be contoured up to
~ 1 cm above the PTV. This, in turn, implies that absolute volume of bowel (in cc) must be used and
respected when setting and evaluating dose constraints.

Femoral Joints:
Can be defined per NRG atlas definitions as required for the protocol
(https://www.nrgoncology.org/ciro-gastrointestinal)

5.2.6 Dose Prescription

Note: The information provided in this section can be used for adjusting the dose constraints for
treatment planning purposes. This table together with the planning priority table should be used
during dose optimization. It is important to remember that ideal plans might not be achievable in all
cases. Thus, the Compliance Criteria table could be different than the information given here. Cases
will be scored using the Compliance Criteria table.

Target Dose (Gy) Fraction Size (Gy) # of fractions Dose specification

Standard Name technique

Covering
PTV_4500 45 1.8 25
95% of PTV*
Covering
PTV_5040 50.4 1.8 3
95% of PTV*
*Prescribe to the isodose line that covers 95% of the PTV, or inverse plan to cover 95% of the PTV with the prescription
dose

5.2.7 Compliance criteria

The compliance criteria listed here will be used to score each case. Given the limitations inherent in
the treatment planning process, the numbers given in this section can be different than the prescription
table. The Per Protocol and Variation Acceptable categories are both considered to be acceptable.
The Per Protocol cases can be viewed as ideal plans, and the Variation Acceptable category can
include more challenging plans that do not fall at or near the ideal results. A final category, called
Deviation Unacceptable, results when cases do not meet the requirements for either Per Protocol or
Variation Acceptable. Plans falling in this category are considered to be suboptimal and additional
treatment planning optimization is recommended.

VxGy[cc], VxGy[%], Vx%[cc], Vx%[%]: Volume [cc or %] receiving Dose [Gy, or %]

CVxGy[cc],CVxGy[%],CVx%[cc],CVx%[%]:Complement Volume [cc or %] receiving Dose [Gy, or
%]
Dxcc[Gy], Dxcc[%], Dx%[Gy], Dx%[%]: Dose [Gy or %] to Volume [cc or % of total volume]
Minimum dose is defined to D99%[Gy] or D99%[%]
Maximum dose is defined as D0.03cc[Gy] or D0.03cc[%]
Mean[Gy] or Mean[%]: Mean dose in Gy or %
R100%: Ratio of 100% isodose volume over structure volume [SBRT only]
R50%: Ratio of 50% isodose volume over structure volume [SBRT only]

Normalization of Dose: For normalization purposes two treatment plans are generated, one for each
phase of treatment (initial 45 Gy and subsequent boost to 50.4 Gy). Each plan is normalized to cover
95% of the PTV with the prescription dose (i.e. D95% = prescription dose) as described in the
prescription section (Section 5.4.5). A combination (plan sum) is required to evaluate the dosimetric
compliance criteria for critical structures.

Note: Deviation Unacceptable occurs when dose limits for Variation Acceptable are not met

Target Volume Constraints and Compliance Criteria

Variation
Name of Structure Dosimetric parameter Per Protocol
Acceptable
D95%[Gy] =45 44.1 to 45.9
PTV_4500
D10%[Gy] <=49.5 <=54

D99%[%] >=93 >90

D99%[Gy] >=41.9 >40.5

D95%[Gy] =50.4 49.4 to 51.4

D10%[Gy] <=55.4 <=60.5

PTV_5040
D99%[%] >=93 >90
D99%[Gy] >=46.9 >45.4

Per Protocol range is excluded from Variation Acceptable range.

Normal Structure Constraints and Compliance Criteria

Dosimetric Variation
Name of Structure Per Protocol
parameter Acceptable
Bowel_Small D150cc[Gy] <=15 <=16.5
D120cc[Gy] <=35 <=38.5
D70cc[Gy] <=40 <=44
D35cc[Gy] <=45 <=49.5
D0.03cc[Gy] <=50 <=55
Femur_Head_L D50%[Gy] <=30 <=33
D40%[Gy] <=40 <=44
D5%[Gy] <=45 <=49.5
D0.03cc[Gy] <=50 <=55
Femur_Head_R D50%[Gy] <=30 <=33
D40%[Gy] <=40 <=44
D5%[Gy] <=45 <=49.5
D0.03cc[Gy] <=50 <=55
Bladder Mean[Gy] <=40 <=44
E-PTVs D1cc[Gy] <=50.4 <=54.5
Per Protocol range is excluded from Variation Acceptable range.

Recommended dose acceptance criteria for other normal tissue, but not to be used for plan
score.

Delivery Compliance criteria

Per Protocol Variation Notes

Acceptable (Please remove this
column when notes
are not needed)
Start date (X days/weeks after X)
(Please remove this row when the
start date is not specified in the
protocol.)
Overall Treatment time
Interruptions
5.2.8 Treatment Planning Priorities and Instructions

- Critical Structure and Target priorities are be listed in order of decreasing importance. Use these
priorities when not all planning constraints can be met:
1. PTV_5040
2. PTV_4500
3. Small bowel
4. Femoral head
5. Bladder

- Required algorithms

Acceptable choices of algorithm are listed at http://rpc.mdanderson.org/RPC/home.htm

For Convolution/Superposition type algorithms, dose should be reported as computed inherently by

the given algorithm. For Monte Carlo or Grid Based Boltzmann Solver algorithms, conversion of Dm
(dose-to-medium) to Dw (dose-to-water) should be avoided. Dm, computed inherently by these
algorithms, should be reported. These principles hold for Pencil Beam type algorithms and for
homogeneous dose calculations when allowed for a clinical trial (e.g., conical collimators in
stereotactic radiosurgery).

- Primary dataset for dose calculation

-Dose matrix resolution

Dose grid size should be ≤ 3 mm in all directions.

Either a 3D conformal radiotherapy planning technique or IMRT may be used. If not using IMRT,
field edges and MLC blocking must be conformal to the PTVs. The dose distributions must include
corrections for tissue density heterogeneities. Regardless of planning technique, the dose prescription
criteria specified in the section on compliance criteria (Section 5.2.7) must be used.
-List treatment planning recommendations and give link to FAQs

5.2.9 Patient specific QA

Any patient-specific QA that needs to be performed should follow institutional guidelines.

5.2.10 Treatment Localization/IGRT

Image-guided radiation therapy (IGRT) is radiation therapy using imaging to facilitate accuracy and
precision throughout its entire process. In this section we use the terminology IGRT to focus on
image-guidance at the time of radiation delivery to ensure its adherence to the planned treatment, with
computer assisted process, i.e. image handling together with calculation of shift and rotations (if
available) must be determined with computer assistance.

The following information should be provided for localization guidance

* Will simple isocenter localization technique be used at beginning of treatment and weekly
thereafter?
* Are all IGRT techniques included?
* Is IGRT tied to margin reduction?
* The time points of imaging (e.g. before, mid, after treatment)? This should be decided based on
immobilization, treatment margin, etc.
* Allowed image guidance methods: 2D x-ray, 3D-xray, electromagnetic localization, optical surface
imaging, other
   Image registration techniques: fiducial markers, bone as surrogate, soft tissue, other
* Give recommendations for correcting (e.g. correcting for linear shifts less than 1 mm is not
recommended)
* Other

Daily IGRT localization is required for patients treated with IMRT. Either a daily orthogonal kV pair
with fiducials or CBCT (or MVCT) is acceptable. The boost plan should be imaged with daily CBCT.
Institutional guidelines should be followed for daily treatment localization and IGRT. For patients not
treated with IMRT, patients should be imaged with an Orthogonal kV (2D) image pair or CBCT (or
equivalent) prior to the first fraction, and weekly or more frequently thereafter. IGRT credentialing is
not required for this protocol.

5.2.11 Case Review

The Principal Investigators, XXX, MD will perform ongoing remote RT Quality Assurance Review
after cases enrolled have been received at IROC Philadelphia-RT.