Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

• Status: Unknown status
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.

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

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum

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

• Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography

• ECOG performance status 0-2

• No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway targeting therapy

• Adequate organ functions

• Patients must sign the informed consent

Exclusion Criteria:

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

• Any defined hereditary colorectal cancer

• Any unresected synchronous colon cancer

• R0 resection of tumor is not clinically possible

• 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 with 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

• History of severe pulmonary disease

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