Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Neoadjuvant Therapy Clinical Trial

Official title: A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

This study is an open-label, single center, nonrandomized phase II study. Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor were delivered concurrently with chemotherapy.

Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 & 29).

Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed.

Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoadjuvant Therapy
• Rectal Neoplasm
• Rectal Neoplasms

• NCT number: NCT00506623
• Study type: Interventional
• Source: National Cancer Center, Korea
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2004
• Completion date: December 2008