Room: Exhibit Hall
Purpose: To describe the credentialing process for randomized photon vs. proton NCI sponsored trials.
Methods: IROC Houston issues credentialing letters for approximately 75 different NCI sponsored clinical trials from the NCTN study groups. The process for credentialing begins with a Credentialing Status Inquiry (CSI) Form, which is completed by a site that would like to be credentialed. New protocols comparing photon vs. proton treatments have emerged that require sites to simultaneously credential a photon and proton site for randomization. Individually, sites must meet the protocolâ€™s requirements which range from having an updated Facility Questionnaire and phantom irradiation for both proton and photon to receiving baseline approval for proton sites. The baseline proton approval consists of a site visit, proton Facility Questionnaire, TLD output check, and successful completion of the baseline phantoms (prostate and spine for all modalities, plus the lung phantom for pencil beam scanning). Distinctively new for credentialing of these protocols is the submission of a Letter of Intent (LOI) by both sites to NRG Oncology Regulatory to participate as partners in the given trial.
Results: Currently, three NCI sponsored trials exist that require this new simultaneous credentialing of photon and proton sites: NRG-BN005, RTOG-1308 and NRG-GI003. In addition, NRG-BN001 requires dual credentialing if a proton site wishes to be credentialed; however, the photon site may be credentialed on its own. As of February 2018, NRG-BN005 has accumulated 7 proton sites with 10 partner photon sites. 10 and 4 proton/photon sites have been credentialed for RTOG-1308 and NRG-GI003, respectively.
Conclusion: Trials randomizing between protons and photons require for sites with these modalities to partner in their credentialing activities. This task can be accomplished efficiently when both sites know the requirements.
Funding Support, Disclosures, and Conflict of Interest: This work was supported by the NCI grant # CA180803.
Not Applicable / None Entered.