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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


Phase 2/Phase 3
20 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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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

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