Abstract
Purpose: To describe the approval process for enrolling patients on NCI‐funded cooperative group clinical trials with proton therapy and the impact of data obtained from the process. Methods: Institutions interested in participating in clinical trials with proton therapy must first complete five RPC‐coordinated approval steps for each proton delivery Method: a) completion of the proton facility questionnaire; b) annual monitoring of beam output; c) electronic transfer of treatment plans; d) successful completion of baseline anthropomorphic proton phantoms; and e) successful completion of a dosimetry review visit and corresponding site visit report. The RPC implemented a new fee structure for proton therapy site visits on 1/1/2013, establishing a cost‐share between the NCI/MGH Federal Share Funds and the institutions visited. These visits consist of QA review as well as dosimetric measurements with an ion chamber, 2D ion chamber array, and multi‐layer ion chamber to evaluate treatment delivery. Once an institution is approved for clinical trials with protons, there may be additional credentialing for specific trials, such as irradiations of the RPC's protocol‐specific anthropomorphic proton phantoms. Results: To date, the RPC has approved eight proton centers for use of proton therapy in clinical trials. These approvals cover scattered, uniform scanning, and spot scanning proton therapy delivery techniques. The RPC has performed 12 proton therapy site visits and has consensus data to establish acceptance criteria for site visit measurements that will ensure clinical trial consistency. With some institutions going through the approval process for a second or third delivery modality, the RPC anticipates eight proton centers will have 12 new beam delivery systems approved for use of proton therapy in clinical trials by the end of 2013. Conclusion: The RPC's proton therapy approval process and credentialing requirements help ensure consistency across clinical trial participants. Work supported by grants CA10953, CA059267, and CA81647 (NCI, DHHS).
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