NSABP B-51 / RTOG 1304 Requirements

 

Please fill out the credentialing status inquiry form to let us know that you would like to be credentialed for this protocol.

This protocol requires each institution to submit electronic patient data to RTOG using TRIAD. For instructions on TRIAD, click here. Please note, with CTSU integration with TRIAD, IRB approval is required in order to submit credentialing data. Please note, data should no longer be submitted to ITC.

This protocol is a randomization between two Arms and under each arm there are two Groups.This study requires each institution to complete a benchmark case for Arm 2/Group 2A. The institution may decide which modality (3DCRT or IMRT) to use for the Arm 2/Group 2A benchmark, however at least one benchmark must be for each modality that the institution would like to be credentialed for to use for protocol patients. Each institution must complete the credentialing process before a patient can be placed on the protocol (See Section 4.1 of the protocol). Once the institution has met the minimum requirements for credentialing, NSABP will send a letter to the lead Radiation Oncologist, Physicist, Dosimetrist and data manager, as specified on the facility questionnaire, stating that their institution has successfully completed the credentialing process, for a specific arm and group of the study, and can begin placing patients on the study.

All Institutions must complete the following:

Step 1:

Update the electronic IROC Houston Facility Questionnaire. A password protected link has been supplied to the institution’s primary clinical trial physicist or can be obtained by contacting the IROC Houston at IROCHouston@mdanderson.org

Step 2:

All the Benchmark cases, and study patient cases on this trial need to be submitted digitally to the TRIAD. For each case, please submit both the 50 Gy plan and the boost (12 Gy or 14 Gy) plan, but not as a composite plan.

3D-CRT Credentialing / IMRT Credentialing (see note 1)

This study requires each institution to complete a benchmark case for Arm 2/Group 2A. The institution may decide which modality 3DCRT and/or IMRT they wanted to be credentialed for.

If a site would like to be credentialed for 3D only then Arm 2/Group 2A benchmark will be done using 3D CRT. If a site would like to be credentialed for IMRT only, then the Arm 2/Group 2A benchmark needs to be done using IMRT.

If an institution wishes to be credentialed for both modalities, 3D CRT & IMRT then two Arm 2/Group 2A benchmark cases will need to be submitted, one must be planned using IMRT and the other using 3DCRT.

If a site is credentialed for 3D CRT only, and wishes to be credentialed for IMRT, then the site needs to submit a Benchmark case for Arm 2/Group 2A that is planned with IMRT, and vice versa for IMRT.

Arm 2 Group 2A Benchmark (Lumpectomy: Regional nodal XRT with WBI)

• If credentialing for IMRT, an irradiation of the IROC Houston's IMRT H&N phantom is required (see note 1). Please fill in the request form online

Arm 1 Group 1B (NO Credentialing) (Mastectomy: No regional nodal XRT and no chestwall XRT)

Step 3:

Please complete the Dosimetry Summary Form (For each patient / Benchmark)

Note:

•  Institutions that are credentialed to participate in other IMRT protocols requiring an IMRT H&N phantom irradiation need not repeat the phantom irradiation for credentialing for this protocol.

•  Click here to access the DVA being used to evaluate all NSABP B51 patients.