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Technical Aspects of Credentialing for the NSABP B-51 / RTOG 1304 Trial


J Lowenstein

J Lowenstein1*, H Nguyen1 , A Hollan1 , J Galvin2 , D Followill1 , (1) UT MD Anderson Cancer Center, Houston, TX, (2) Thomas Jefferson Univ Hospital, Philadelphia, PA,

Presentations

SU-E-T-311 Sunday 3:00PM - 6:00PM Room: Exhibit Hall

Purpose:
For each of this trials 3 treatment scenarios an institution must be credentialed. The purpose of credentialing is to verify all personnel involved with treatment planning have read the protocol and can follow the protocol specifications prior to placing a patient on protocol with the end result of limiting the number of protocol deviations. Credentialing also provides feedback to an institution prior to treatment of a patient on trial to correct any mistakes that may occur.

Methods:
An institution needs to update their Facility Questionnaire and download the 3 CT benchmark cases representing the 3 treatment groups (1A, 2A and 2B) of the study from the RPCs website. The institution may decide which modality (3DCRT/IMRT) to use for each benchmark, however at least one benchmark must be completed for each modality for which the institution wants to be credentialed. The RPC reviews these benchmarks using MIM for verification that dose requirements are per protocol.

Results:
Presently, 101 institutions have initiated the credentialing process. 94 institutions have submitted their benchmarks, 7% failed and never resubmitted a benchmark for re-review. The breakdown of credentialed techniques is; 4% IMRT only, 52% 3DCRT only and 44% 3DCRT/IMRT. Of those sites that have been credentialed: 6% of the institutions failed the benchmark for 1A, 11% failed for 2B and 40% failed for 2A at least once, before being credentialed. 9% of the institutions failed 2A twice and 1 institution failed three times.

Conclusion:
Currently 87 institutions have been credentialed for this study. The protocol has accrued 9 patients which have all been pre-treatment reviews where 2 of them had to be re-submitted for a re-review due to volume contouring.

This work was supported by PHS grant CA 10953 awarded by NCI, DHHS.



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