RTOG 1308 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.

Proton centers must have a partner photon center to be credentialed and vice versa. All sites must submit a Letter of Intent (LOI) to NRG Oncology Regulatory to receive approval to participate in this trial. You can find the LOI on the CTSU website. Select the trial, and the LOI form can be found under Documents/Site registration. The LOI contains instructions on how to submit it to NRG for review.

This study requires credentialing before patients can be entered onto this study. The credentialing requirements are different depending on whether you are using a 3D-CRT, IMRT or proton therapy technique. You can be credentialed for one technique or for all, depending on your physician's treatment preference.

In order to complete the 3D-CRT credentialing process, the following items must be completed:

• All participants are asked to update an existing or complete a new Facility Questionnaire

• All participants must complete IGRT credentialing for soft tissue alignment. Please also complete the IGRT questionnaire.

•  Completion of the 1308 Knowledge Assessment is required. Please note, only 1 knowledge assessment is required per institution.

In order to complete the IMRT credentialing process, the following items must be completed:

• All participants are asked to update an existing or complete a new IMRT Facility Questionnaires

• Irradiate the IROC Houston's lung phantom using an IMRT technique. Please fill in the request form online.

• All participants must complete IGRT credentialing for soft tissue alignment. Please also complete the IGRT questionnaire.

•  Completion of the 1308 Knowledge Assessment is required. Please note, only 1 knowledge assessment is required per institution.

Institutions credentialed for IMRT for this protocol are automatically credentialed for the use of 3D-CRT

In order to complete the Proton Therapy credentialing process, the following items must be completed:

• Successful completion of the IROC Houston proton thorax phantom irradiation and review. Please fill in the request form online.

• Complete and submit a Facility Questionnaires to RTOG

•  All participants must complete IGRT credentialing for soft tissue alignment. Please also complete the IGRT questionnaire.

•  Completion of the 1308 Knowledge Assessment is required. Please note, only 1 knowledge assessment is required per institution.

•  Successful completion of the IROC Houston proton approval requirements (baseline phantoms, electronic data transfer, annual output check, site visit, and proton questionnaire).

Note:

• Institutions that have been successfully credentialed for prior RTOG lung studies will automatically qualify for this study using the same delivery technique (3D-CRT vs IMRT) as previously credentialed for. If you would like to verify your previous credentialing status, please fill in the Credentialing Status Inquiry Form and a staff member from the IROC Houston will contact you.

• Institutions that have successfully irradiated the lung, spine or H&N phantom using IMRT delivery are not required to repeat the phantom irradiation as long as the TPS, algorithm for heterogeneity corrected dose calculation, type of delivery (eg. step&shoot IMRT vs. VMAT) has not changed. If you would like to verify your previous phantom irradiations, please fill in the Credentialing Status Inquiry Form and someone from the IROC Houston will contact you.

• NCI Guidelines on the use of IMRT in Clinical Trials

•  Acceptable treatment planning system(TPS) / algorithm