Status:
COMPLETED
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Serious drug hypersensitivity
- Pregnant or nursing
- Bleeding from gastrointestinal tract
- Diarrhea
- Simultaneously active double cancer
- Serious illness or medical condition
- Brain metastasis
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00891332
Start Date
October 1 2008
End Date
November 1 2011
Last Update
January 18 2012
Active Locations (6)
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1
Sun Yat-sen University Cancer Center, Division of Oncology
Dong Feng Dong road,Guangzhou, Guangdong, China, 510060
2
Shanghai Fudan University Cancer Hospital, Division of Oncology
Dong An Road, Shanghai, China, 200032
3
PLA 307 Hospital, No.4 Division of Oncology
East Avenue, Fengtai District, Beijing, China, 100071
4
Beijing Cancer Hospital, Digestive System Medicine Department
Fucheng Road, Haidian District, Beijing, China, 100036