Rapid online feedback to improve clinical trial accrual: CODEL anaplastic glioma (AG) (NCCTG/Alliance N0577) as a model.

Authors

null

Holly Massett

National Cancer Institute, Rockville, MD

Holly Massett , Kurt A. Jaeckle , David M. Dilts , Andrea Denicoff , Erin Souhan , Jenny R Hopkins , Bhupinder Singh Mann

Organizations

National Cancer Institute, Rockville, MD, Mayo Clinic, Jacksonville, FL, Oregon Health & Science University, Portland, OR, EMMES Corporation, Rockville, MD, Westat, Inc., Rockville, MD, National Cancer Institute, National Institutes of Health, Bethesda, MD

Research Funding

No funding sources reported

Background: Structured feedback from community oncologists regarding trial design rarely occurs. Survey templates were created to assess trial feasibility, design and scientific interest from the community, with the aim of improving accrual. We report results from a survey regarding redesign of the Phase III CODEL trial for newly diagnosed 1p/19q codeleted AG, which employed this approach. Methods: A field-tested, online survey template was tailored for CODEL and emailed to U.S. and international oncologists. The survey assessed (a) practice changes resulting from ASCO 2012 data from RTOG 9402 (abstract # 2008b) and EORTC 26951 (abstract # 2); (b) scientific interest in a redesigned trial; and (c) potential accrual issues. Respondents reviewed a brief trial concept and answered 15 questions anonymously via a web-based system. Results: 173 oncologists completed the survey over 2 weeks in Sept 2012(48% US, 52% Int’l; 35% med oncs, 31% rad oncs, 29% neuro-oncs). Results from the 2 prior studies substantially influenced clinicians’ treatment decisions for patients with newly diagnosed 1p19q codeleted AG--from only 9% recommending RT+PCV prior to the ASCO reports, to 46% after the results were presented. Previously, 25% recommended RT alone, and after ASCO, no one did. Most indicated strong interest in the revised CODEL research questions, trial design, randomization arms, and in re-opening the revised trial. The most interesting schema was a 3-arm design (selected by 45% of respondents): (RT + procarbazine, CCNU and vincristine chemotherapy [PCV]) vs. (RT + Temozolomide [TMZ]) vs. (TMZ alone), with neuro-oncs (49%) preferring it most, and rad oncs least (36%). The second most interesting choice (27%) was RT+PCV vs. RT+TMZ; the third choice (20%) was RT+TMZ vs. TMZ alone. Most (61%) felt patients would accept any arm. Respondents encountered eligible patients frequently enough to meet projected CODEL accrual goals. Conclusions: Survey findings significantly influenced decisions on how best to redesign the CODEL trial. Rapid, web-based surveys of community oncologists can provide important feedback regarding level of interest, which might facilitate timely accrual and trial completion.

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Cancer Prevention/Epidemiology

Track

Cancer Prevention/Epidemiology

Sub Track

Epidemiology

Citation

J Clin Oncol 31, 2013 (suppl; abstr 1596)

DOI

10.1200/jco.2013.31.15_suppl.1596

Abstract #

1596

Poster Bd #

9A

Abstract Disclosures