Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)

• Registration Number: NCT00891332
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2011-07
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Histologically proved adenocarcinoma
• Unresectable and recurrent colorectal cancer
• Age20 ≤ at enrollment
• Performance status 0 or 1 (ECOG)
• No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
• Adequate hematologic, hepatic and renal functions
• At least one measurable lesion by RECIST criteria

Exclusion Criteria

• Serious drug hypersensitivity
• Pregnant or nursing
• Bleeding from gastrointestinal tract
• Diarrhea
• Simultaneously active double cancer
• Serious illness or medical condition
• Brain metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	S-1 plus LV (The combination therapy of S-1 and Leucovorin)	S-1 plus LV

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	During chemotherapy

Secondary Outcome Measures

Name	Time	Method
Safety	During chemotherapy
Progression free survival (PFS)	Until progression
Disease control rate(DCR)	During chemotherapy
Time to treatment failure (TTF)	Until progression
Overall survival (OS)	Over two years from registration
Feasibility	During chemotherapy
Pharmacokinetics	During chemotherapy

Trial Locations

Locations (6)

PLA 307 Hospital, No.4 Division of Oncology; 🇨🇳 East Avenue, Fengtai District, Beijing, China

Beijing Cancer Hospital, Digestive System Medicine Department; 🇨🇳 Fucheng Road, Haidian District, Beijing, China

Shanghai Fudan University Cancer Hospital, Division of Oncology; 🇨🇳 Dong An Road, Shanghai, China

Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology; 🇨🇳 Panjiayuan Nanli, Chaoyang District, Beijing, China

Sun Yat-sen University Cancer Center, Division of Oncology; 🇨🇳 Dong feng Dong road,Guangzhou, Guangdong, China

Graduate School of Medical Sciences Kumamoto University; 🇯🇵 1-1-1, Honjo Kumamoto-city, Kumamoto, Japan