Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
Phase 2
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
- Registration Number
- NCT00721916
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Inclusion Criteria
- Histologically proved adenocarcinoma (colorectal cancer).
- Age: 20 ≤ at enrollment.
- 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 or Oxaliplatin containing treatment shall be excluded.
- At least one measurable lesion by RECIST criteria
Exclusion Criteria
- Serious drug hypersensitivity.
- Prior history of peripheral neuropathy.
- Diarrhea .
- Simultaneously active double cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) 2 mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) Until progression
- Secondary Outcome Measures
Name Time Method Safety During chemotherapy
Trial Locations
- Locations (1)
Shizuoka Cancer Center
🇯🇵Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan