NCT01110941

Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China

A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shen Lin · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.

Detailed description

* Endpoints: * Primary endpoints: adverse drug reaction * Secondary endpoints: * Overall Response Rate：ORR * Progress Free Survival: PFS * Time to Treatment Failure：TTF

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	S-1, leucovorin, oxaliplatin	S-1(20mg、25mg), capsule, 40\~60mg, Bid,p.o., day1\~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1\~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-10-01
• First posted: 2010-04-27
• Last updated: 2015-05-19

Locations

1 site across 1 country: China