Rectal Cancer Clinical Trial
Official title:
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer
The objectives of this study are to:
1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a
combination regimen with capecitabine and radiotherapy (Phase 1)
2. To determine the maximum-tolerated dose (MTD) when capecitabine
- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination
with capecitabine and radiotherapy (Phase 2)
Part of the treatment plan for this study is surgical removal of the tumor that is planned to
occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct
phases (Phase 1 and Phase 2).
In Phase 1, the objectives are to
1. Assess dose-limiting toxicities (DLTs) and
2. Determine a maximum-tolerated dose (MTD)
The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of
the chemo-radiotherapy regimen at defined timepoints that precede surgery.
Phase 2 is the efficacy assessment portion of this study. In Phase 2, the objective is to
accrue an expansion cohort. Efficacy assessments for phase 2 are to be assessed across all
study participants at the time of, or after, surgery, as measured by the pathologic response
rate; downstaging; and survival at 5 years from the start of treatment.
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|---|---|---|---|
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