Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Collaborator: Yakult Honsha Co., LTD
• Treatments: Leucovorin; Oxaliplatin

Criteria

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.