Trial Information
Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer
Inclusion Criteria:
- Histologically confirmed colorectal cancer
- Locally advanced and/or metastatic colorectal cancer
- Have prior chemotherapy as first line treatment
- No prior irinotecan administration
- Able to take oral medication
- Age 20 to 75
- Performance status 0 or 1 (ECOG)
- WBC 3,000-12,000 / mm^3
- Platelet ≥100,000 / mm^3
- AST and ALT ≤ 100 IU/L
- Creatinine ≤ 1.2 mg/dL
- Bilirubin ≤ 1.5 mg/dL
Exclusion Criteria:
- Prior radio therapy for colorectal cancer
- Other malignancies in the past 5 years
- Serious illness or medical condition
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
Outcome Time Frame:
every course for first three courses, then every other course
Safety Issue:
Yes
Principal Investigator
Kenichi Sugihara, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tokyo Medical and Dental University Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
01023010 / TOP-003
NCT ID:
NCT00284258
Start Date:
January 2006
Completion Date:
August 2010
Related Keywords:
- Colorectal Cancer
- Colorectal Cancer
- Colorectal Neoplasms