Download Required/Required when applicable/Optional

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5.2
Radiation Therapy
Notes 1,2,…: The note(s) included at this point in the protocol should be designed to emphasize
special information that the study chair does not want the investigator to overlook. An example might
be a statement that IGRT is required for the study.
Radiation Therapy Schema
Schema at the beginning of the protocol should be followed.
5.2.1 Treatment Technology
List allowed Treatment Modalities (including energy): photons, protons, electron, brachytherapy, …..
Required Capabilities: IMRT, IGRT, etc.
This protocol requires photon treatment. 3D-CRT, IMRT techniques includingTomotherapy and
VMAT are allowed. ViewRay, CyberKnife are allowed. All patients will have daily IGRT.
5.2.2 Immobilization and Simulation
Immobilization
Proper immobilization is critical for this protocol. Patient setup reproducibility must be achieved
using appropriate clinical devices.
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.
Efforts should be made so that simulation CTs take place before initiation of metformin therapy.
Contiguous CT slices of 3 mm slice thickness should be obtained starting from the level of the cricoid
cartilage and extending inferiorly through the entire liver volume. If simulation is performed prior to
the initiation of metformin therapy, I.V. contrast should be administered while acquiring the CT used
to define the treatment volume. If simulation is performed after initiation of metformin therapy,
contrast enhancement during CT-simulation will not be permitted and contrast-enhanced diagnostic
CTs and PET/CTs should be used to guide tumor and normal organ volume definition. In the case in
which contrast is present during the treatment planning CT, the density of the contrast should be
overridden to a representative background electron density.
Motion Management Technique
Please remove this subsection when motion management is not used.
Motion management is highly recommended for this protocol. In instances in which motion
management is not possible, larger expansion volumes will be used to adequately cover the motionrelated uncertainties. The types of motion management allowed on this study are 4DCT, active breathhold, gated breathing, and abdominal compression.
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 will be required as part of staging and 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.
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 Name
Description
Validation
Required/Required when
applicable/Optional
GTV_7000
GTV to receive 70
Gy
Required
IGTV_7000
Volume enveloping
GTV motion over
the course of a
respiratory cycle
CTV_7000
CTV to receive 70
Gy
PTV_7000
PTV to receive 70
Gy
Required when applicable
Required
Required
PTV_7000
PTV to receive 70
Gy
Required
PTV_Eval_7000
PTV minus OARs
Required when applicable
PTV+20
Volume defined to
control intermediate
dose spillage, 2 cm
from PTV
Required
Detailed Specifications
Target volumes: The definitions of volumes will be in accordance with the 1999 ICRUReport#62.
Accounting for Tumor Motion Approaches and Internal and Setup Margins
Internal margin (IM): The IM used will be dictated by the motion management decision made at time
of simulation.
1.
If the simulation is done with a free-breathing CT only, the IM will be 1 cm in the superiorinferior direction and 0.5 cm in the axial direction.
2.
If simulation is done with abdominal compression, the IM will be 0.8 cm in the superiorinferior direction and 0.5 cm in the axial direction.
3.
If simulation is done using an active breath-hold or gated breathing technique, the IM will be
0.5 cm in all directions.
4.
If simulation is done using a 4DCT to develop a maximum intensity projection of the tumor
volume, no IM is needed.
Setup margin (SM): Daily IGRT is a requirement for this trial; therefore, the SM will be 0.5 cm in all
directions.
GTV_7000: The primary tumor and clinically positive lymph nodes seen either on the planning CT
(> 1cm short axis diameter) or pre-treatment PET scan (SUV > 3) will constitute the GTV. This
volume(s) may be disjointed. In the event of a collapsed lobe or lung segment, the use of PET to
distinguish tumor from fluid/atelectasis is encouraged.
CTV_7000:The CTV is defined to be the GTV plus a 0.5cm to 1cm margin as appropriate to account
for microscopic tumor extension. If an IGTV is used then a 0.5cm to 1cm margin is added to the
IGTV to form a CTV
PTV_7000:The PTV will be equal to the CTV+IM+SM. IM and SM are defined in section above. In
cases in which the PTV expansion extends outside of the skin, towards the spinal cord or into the
spinal canal, it can be assumed that tumor motion will not occur in this direction, and the PTV margin
in this direction can be limited. PTV margin can be limited up to 0.5cm towards this particular
dimension (skin or spinal canal).
Margins added to CTV (cm): Cranial: 2;Caudal: 2;Anterior: 2;Posterior: 2;Lateral: 2;Medial: 2;Other
notes
PTV_Eval_7000:PTV volume minus impinging OARs for dosimetric evaluation
PTV+20:PTV expanded by 2 cm in all directions
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.
Standard Name
Description
Parotid_R
Right parotid gland
Validation
Required/Required when
applicable/Optional
Required
SpinalCord
Spinal Cord
Required
SpinalCord_PRV
PRV to the spinal cord
Optional
Esophagus
Esophagus
Required
Detailed Specifications
SpinalCord :Boundaries: Cranial:1st slice of CT; Caudal: last slice of CT;
SpinalCord_PRV:Boundaries: Uniform 3 mm expansion in all directions
Esophagus:Boundaries:Cranial: Bottom of cricoid; Caudal: GE junction;
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
Standard Name
Dose (Gy)
Fraction
Size (Gy)
# of
fractions
Frequency
PTV_6000
60
2.0
30
Daily
Dose
specification
technique
Covering
95% of PTV
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:The plan is normalized such that 95% of the PTV_6000 volume receives
prescription dose of 60 Gy.
Note: Deviation Unacceptable occurs when dose limits for Variation Acceptable are not met
Target Volume Constraints and Compliance Criteria
Name of
Structure
Dosimetric
parameter*
Per
Protocol
Variation
Acceptable
PTV_6000
D95%[Gy]
D99%[Gy]
D0.03cc[Gy]
60
>=54
<=66
58.8 to 61.2
>=51
<=69
Per Protocol range is excluded from Variation Acceptable range.
Notes
(Please remove
this column
when notes are
not needed)
Normal Structure Constraints and Compliance Criteria
Name of
Structure
Dosimetric
parameter
Lungs
V5Gy[%]
V20Gy[%]
Mean[Gy]
Per Protocol
Variation
Acceptable
Endpoint/Notes
(Please remove
this column
when notes are
not needed)
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.
Structure
Larynx
Pharynx
E-PTV
Mandible
Recommended dose acceptance criteria
Mean[Gy]<= 30
Mean[Gy]<=40
D1cc[Gy]<=63
D0.03cc[Gy]<= 63
Delivery Compliance criteria
Per Protocol
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
Variation
Acceptable
Notes
(Please remove this
column when notes
are not needed)
5.2.8 Treatment Planning Priorities and Instructions
- Critical Structure and Target priorities must be listed in order of decreasing importance(We may also
use one importance factor for a group of structures).
The following list is given as an example
1.
Spinal Cord
2.
Brainstem
3.
PTV1
4.
PTV2
5.
Oropharynx
6.
Esophagus
7.
Other
- Required algorithms
(Convolution/Superposition, Monte Carlo, etc…)
Acceptable choices of algorithm are listed at
http://rpc.mdanderson.org/rpc/Services/Anthropomorphic_%20Phantoms/TPS%20%20algorithm%20list%20updated.pdf. Any algorithm used for this study must be credentialed by
IROC Houston.
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
The primary dataset for dose calculation must be a free-breathing CT that was acquired along with
4DCT, an average intensity pixel CT (AveIP) generated from the 4DCT, the breath-hold/gated CT, or
the free-breathing CT acquired with no other motion management. Maximum Intensity Pixel (MIP)
generated images from 4DCTs may not be used as the primary dose calculation dataset. In the case in
which contrast is present during the treatment planning CT, the density of the contrast should be
overridden to a representative background electron density.
-Dose matrix resolution
Dose grid size should be ≤ 3 mm in all directions.
-List treatment planning recommendations and give link to FAQs
5.2.9 Patient specific QA
- Describe technique and give Gamma pass rate recommendation
For IMRT/VMAT/proton plans, patient specific QA is highly recommended. Any patient-specific QA
performed should follow your institutional guidelines. The recommended patient specific QA criteria
is for 90% of the comparison points to pass a ±3%/3mm Gamma Index analysis.
For passive scattered or uniform scanned beam plans that utilize a patch field, patient specific QA
must be performed with the compensator.
For IMPT plan QA, measurement in multiple layers is required.
5.2.10Daily TreatmentLocalization/IGRT
Image-guided radiation therapy (IGRT) is radiation therapy using imaging to facilitate accuracy and
precision throughout its entire process from target and normal tissue delineation, to radiation delivery,
to adaptation of therapy to anatomic and biological changes over time in individual patients. 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.
The following information should be provided for Localization guidance
 Will simple isocenter localization technique be used at beginning of treatment and weekly
thereafter?
 Will more advanced IGRTtechniques be used?
 Is IGRT tied to margin reduction?
 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
 State the frequency for localization checks
 Give recommendations for correcting (e.g. correcting for linear shifts less than 1 mm is not
recommended)
 Recording of shift information must be provided for the IGRT credentialing process
 Other
- Minimal IGRT requirements
Location
Lung*
Liver*
Spinal
Abdominal-pelvic*
No Fiducials
Volumetric (3D)
Volumetric (3D)
Orthogonal kV (2D)
Volumetric (3D)
With Fiducials**
Orthogonal kV (2D)
Orthogonal kV (2D)
Orthogonal kV (2D)
Orthogonal kV (2D)
*Registration using a soft tissue surrogate for the tumor is recommended.
*Free-breathing CTs are not to be used as reference images for 4D CBCT IGRT process
**Clearly visible anatomical markers are acceptable as fiducials, e.g. inserted radio-opage markers or
Lipiodol from prior TACE treatment.
When orthogonal kV imaging is employed for sites where respiratory motion is expected and not
controlled via motion management techniques, care must be taken to ensure accurate targeting of the
ITV within the treatment
Management of Radiation Dose to the Patient from IGRT
NRG Oncology is concerned about the estimated doses given from IGRT, and is committed to limiting
the imaging dose when IGRT is used in any of its protocols. This can be accomplished by avoiding the
use of this technology to make small changes in patient positioning that are within the stated PTV
margins. The imaging dose to the patient may become significant if repeated studies are done for patients
with severe set up problems (e.g. requiring frequent corrections that are larger than the PTV margins).
It is recommended that patients demonstrating severe set up problems during the first week of treatment
be moved to a treatment with larger margins.
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.