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
- 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
- Serious drug hypersensitivity.
- Prior history of peripheral neuropathy.
- Diarrhea .
- Simultaneously active double cancer.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
Outcome Time Frame:
Narikazu Boku, MD
St. Marianna University School of Medicine
Japan: Ministry of Health, Labor and Welfare
- Colorectal Cancer
- Colorectal Neoplasms