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EP075/#462  Radiation quality and workflow in NRG GY017: anti PD-L1 (atezolizumab) as an immune primer or concurrently with RT for node positive locally advanced cervical cancer
  1. Jyoti Mayadev1,
  2. Wei Deng2,
  3. Dmitriy Zamarin3,
  4. Heather Lankes2,
  5. Hayeon Kim4,
  6. Junzo Chino5,
  7. Barbara Banberry6,
  8. Ned Sherry6,
  9. Sharad Ghamande7,
  10. Catherine Ferguson7,
  11. Loren Mell1,
  12. Laura Hollman8,
  13. Cara Matthews9,
  14. David Omalley10,
  15. Alexander Olawaiye4,
  16. Elizabeth Hopp11,
  17. Roisin O’Cearbhaill12,
  18. Carol Aghajanian13 and
  19. Russell Schilder14
  1. 1UCSD, Radiation, La Jolla, USA
  2. 2NRG Oncology, Statistics, La Jolla, USA
  3. 3MSKCC, Med Onc, New York, USA
  4. 4U Pittsburgh, Radiation, pittsburgh, USA
  5. 5Duke, Radiation, durham, USA
  6. 6Adaptive Biotechnology, Adaptive, Seattle, USA
  7. 7Georgia Cancer Center, Augusta University, Gynecologic Oncology, Augusta, USA
  8. 8University of OK, Gyn Onc, OK, USA
  9. 9Brown University, Gyn Onc, Providence, USA
  10. 10OSU, Gyn Onc, Columbus, USA
  11. 11MCOW, Gyn Onc, Milwakee, USA
  12. 12Memorial Sloan Kettering Cancer Center, Gynecologic Medical Oncology Service, New York, USA
  13. 13Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, USA
  14. 14Thomas Jefferson University, Med Onc, Philadelphia, USA


Introduction Advances in RT planning enhance the need for uniform quality oversight on clinical trials. NRG GY-17 was a randomized trial of the anti PD-L1 antibody, atezolizumab, before and concurrent (Arm A) or concurrent with CRT (Arm B). We describe the prospectively collected pre-treatment RT quality and workflow.

Methods 40 patients were consented; 36 patients with locally advanced, LN+ cervical cancer were randomized. IMRT contouring guidelines and dose specifics were outlined in the protocol with deviations specified as per protocol and major. Each site had to pass a rigorous IMRT credentialing process. Sites were required to submit a pre-treatment IMRT plan for physician expert contour target and organ at risk review in a rapid pre-treatment manner. The expert physician then scored the contours and plan as per protocol or as a major deviation. For major deviations the sites were required to revise and resubmit the plans which were then re-reviewed prior to protocol start.

Results The median follow-up time was 20 months. 37 participants had central review of the pre-treatment EBRT plan. 13 plans (35%) were scored as a major deviation requiring revision: 11 due to contours (5 bowel and 6 LN) and 2 due to incorrect expansion/dose. The major deviation plans were resubmitted and passed; 2 required revisions for a total of 3 plans.

Conclusion/Implications Our data indicate that 35% of the submitted advanced technology IMRT plans required revision and resubmission in order to meet per protocol standards. Pre- treatment plan review is an important quality measure for cervical cancer clinical trials.

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