Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer
Status:
Terminated
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
Preoperative induction chemotherapy has been successfully used in a variety of malignancies
and provides several advantages over postoperative therapy. Combination of
5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than
5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has
emerged as a potentially more effective, safe and convenient treatment option for metastatic
colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with
radiation. Recent data has shown that preoperative radiation appears to be significantly more
effective in increasing resectability rates.
This trial will investigate the activity of capecitabine and CPT-11 combination in the
preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal
cancer to improve response and decrease local recurrence. We will also study whether TS, TP,
DPD and carboxyesterase expressions correlate with the objective response rate with this
chemotherapy and chemoradiation regimen.