Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum

• Distal margin of tumor located from 0 to 8 cm from anal verge

• Tumor must be clinically resectable by surgery and R0 resection must be most likely

• ECOG performance status 0-2

• No prior chemotherapy, radiotherapy to pelvis, and immunotherapy

• Adequate organ functions

• Patients must sign an informed consent

Exclusion Criteria:

• Malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease

• Any unresected synchronous colon cancer

• Any distant metastasis

• Intestinal obstruction or impending obstruction, but decompressing colostomy is permitted

• Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix

• Any other morbidity or situation with contraindication for chemoradiotherapy

• Patients have history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine

• Pregnant or lactating women or patients of childbearing potential not practicing adequate contraception