Trial Information
Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival (PFS)
Outcome Time Frame:
Until progression
Safety Issue:
No
Principal Investigator
Narikazu Boku, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Marianna University School of Medicine
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
Taiho10020390
NCT ID:
NCT00721916
Start Date:
July 2008
Completion Date:
May 2012
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms