BeiGene
AdvanTIG-301
Protocol BGB-A317-A1217-301
RT Guidelines and Instructions
A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer
Benchmark Contouring and Dosimetry Review
In order for radiotherapy facilities to be eligible to participate on this trial, the Radiation Quality Assurance Laboratory will issue a credentialing letter. The following steps must be completed to receive credentialing:
- All radiotherapy facilities must successfully complete and submit the Facility Questionnaire and Motion Management Questionnaire
- Irradiation of OSLD for all photon energies
- All radiotherapy facilities must successfully complete the benchmark process. This process includes:
- Download the AdvanTIG benchmark and plan per AdvanTIG-301(BGB-A317-A1217-301 protocol). (See BeiGene RT Manual.)
- Contour the target volumes and organs-at-risk volumes per protocol. Please to be sure to contour the brachial plexus, and create the lungs minus PTV (lungs_PTV); and body minus PTV (body_PTV). These structures are required to be contoured for the benchmark case as well as for live cases on this trial besides other organ at risk (OARs) listed in the protocol. Cases that are missing the required contours will be asked for a resubmit.
- Submit the following data via MD Anderson secure management system:
- Planning CT scan, in DICOM format
- DICOM RT Structure Set
- DICOM RT Plan File
- DICOM RT Dose Files
- Completed Dosimetry Summary Form
If you are unable to send electronically, please contact AdvanTIG-301@mdanderson.org.
Data Submission
For Patient Cases or for Benchmark
- To access the MD Anderson's secure management system to upload data, email a list of names and email addresses for those personnel who should have access to this folder from your site. (Once you have requested access and it is granted, you should not have to request access again.)
- Please create a folder with study subject number within the directory that you have been granted access to in MD Anderson's secure management system. Once you have submitted the data please email us, and in the subject write "DOSIMETRY Benchmark Case for _____ (place institution name)" to notify that the data is available for review.
- If you are unable to send electronically, please email us.
Steps after AdvanTIG-301 trial credentialing
Pre-treatment Subject Dosimetry Review
A pre-treatment subject review of the first patient treatment plan (volume contours & dosimetry review) will be conducted for each radiotherapy center. The first patient is to be contoured and planned per the protocol (See section 5.2.4 of protocol and BeiGene RT Manual). Please submit the patient data as soon as possible as feedback of the treatment plan takes 3 business days upon receipt of a complete submission of all required data. Please leave enough time for revisions if necessary. If changes are requested, site will be asked to re-submit the treatment plan for additional review. Please to be sure to contour the brachial plexus, and create the lungs minus PTV (lungs_PTV); and body minus PTV (body_PTV). These structures are required to be contoured for the benchmark case as well as for live cases on this trial besides other organ at risk (OARs) listed in the protocol. Cases that are missing the required contours will be asked for a resubmit.
Data Submission for Pre-treatment
When submitting patient data, please make sure it has been anonymized or redacted prior to submission. Otherwise, the patient data will be deleted from the MDADL directory, and we will request a re-submission of the anonymized data. The following data must be submitted to submitted to us for review via MD Anderson Cancer Center secure management system:
- Planning CT scan, in DICOM format
- DICOM RT Structure Set
- DICOM RT Plan File
- DICOM RT Dose Files
- Completed Dosimetry Summary Form
After this pre-treatment patient has completed treatment, a final treatment review will be completed to ensure that the treatment received was consistent with the treatment intended. To that end, the following data must be submitted to MD Anderson for review via the same process:
- Daily Treatment Record
If there any questions, please send an email, and in the subject line please include the word DOSIMETRY along with the patient case number assigned by the protocol.
Retrospective Subject Dosimetry Review
A retrospective review will be performed on all patient treatment plans (volume contours & dosimetry review) to verify that the patients were treated per the protocol (See Table 6 in section 5.2.4.2 of the protocol and BeiGene RT Manual). Please submit the patient data as soon as possible so feedback may be provided to the treating site to help educate before the next patient is enrolled on the protocol. When submitting patient data please make sure it has been anonymized or redacted prior to submission, or the patient data will be deleted from the MD Anderson DL directory and we will request a re-submission of the anonymized data. Please to be sure to contour the brachial plexus, and create the lungs minus PTV (lungs_PTV); and body minus PTV (body_PTV). These structures are required to be contoured for the benchmark case as well as for live cases on this trial besides other organ at risk (OARs) listed in the protocol. Cases that are missing the required contours will be asked for a resubmit. The following data must be submitted to us for review via MD Anderson Cancer Center secure management system:
- Planning CT scan, in DICOM format
- DICOM RT Structure Set
- DICOM RT Plan File
- DICOM RT Dose Files
- Daily Treatment Record
- Completed Dosimetry Summary Form
If there any questions, please send an email, and in the subject line please include the word DOSIMETRY along with the patient case number assigned by the protocol.