NCT00506623

Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Rectal Neoplasm
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Capecitabine, Irinotecan

Timeline

• Start date: 2004-07-01
• Completion: 2008-12-01
• First posted: 2007-07-25
• Last updated: 2007-07-25

Locations

1 site across 1 country: South Korea