NCT00190515

A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,101 (actual)
• Sponsor: Haruhiko Fukuda · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.

Detailed description

Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer. UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks. 5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks. Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	5FU+l-leucovorin	5FU+l-leucovorin
DRUG	UFT+Leucovorin	UFT+Leucovorin

Timeline

• Start date: 2003-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2005-09-19
• Last updated: 2016-09-22

Locations

48 sites across 1 country: Japan