NCT00721916

Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)	L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
DRUG	mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)	L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr)

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-03-01
• Completion: 2012-05-01
• First posted: 2008-07-25
• Last updated: 2012-11-01

Locations

1 site across 1 country: Japan