Before an institution can begin the approval process to enroll patients in NCI-funded cooperative group clinical trials , they must be a member of an NCI-funded cooperative group. Currently, both NRG and COG have protocols with proton radiation therapy. See NRG or COG for membership information.
Prior to an institution being allowed to enroll any patients on a cooperative group protocol with proton radiation therapy, an institution must be approved for the use of protons in clinical trials. This approval process consists of:
1. Completion of the proton facility questionnaire.
2. Annual monitoring of the proton beam calibrations by IROC Houston.
3. Ability to electronically transfer treatment plans.
4. Successful irradiation of IROC Houstonís baseline proton phantoms.
5. Successful completion of an on-site dosimetry review visit and visit report to occur only after the center has been routinely treating patients for a minimum of 6 months with no fewer than 3 disease sites.
IROC Houston will coordinate the completion of the approval processes in conjunction with the other quality assurance offices.