A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Our principal objectives in this trial will be to determine if short course radiotherapy
followed by chemotherapy can maintain morbidity at or below levels reported with concurrent
5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while
maintaining response rates comparable to what would be expected with radiotherapy and
concurrent chemotherapy. If we can establish a T stage downstaging rate that is
significantly better than 50% and if acute tolerance is acceptable, then we would consider
this study as having provided sufficient pilot data to support including this approach as an
arm in a multi-institution phase III trial. The long-term goal is improved overall control
of disease by delivering better chemotherapy earlier.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Demonstrate that short course preoperative radiotherapy followed by preoperative chemotherapy will elicit a rate of T stage downstaging comparable to or better than seen with concurrent prolonged course preoperative radiotherapy and chemotherapy.
Time of surgery
12-18 weeks after start of radiation therapy
Parag Parikh, M.D.
Washington University School of Medicine
United States: Institutional Review Board
09-0696 / 201106272
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