Status:
COMPLETED
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Yakult Honsha Co., LTD
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 Oxalipla...
Eligibility Criteria
Inclusion
- 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
- Serious drug hypersensitivity.
- Prior history of peripheral neuropathy.
- Diarrhea .
- Simultaneously active double cancer.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00721916
Start Date
July 1 2008
End Date
May 1 2012
Last Update
November 1 2012
Active Locations (1)
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1
Shizuoka Cancer Center
Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, Japan, 411-8777