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A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)


Phase 3
20 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)


Inclusion Criteria:



- Age 20 to 75

- Performance status 0 , 1, or 2 (ECOG)

- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3

- Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL

- Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL

Exclusion Criteria:

- Prior anticancer treatment

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:

Relapse-free survival and overall survival

Outcome Time Frame:

every course for first three courses, then every other course

Safety Issue:

No

Principal Investigator

Shigeaki Yoshida, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center Hospital East

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

01023002

NCT ID:

NCT00152230

Start Date:

October 1996

Completion Date:

February 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • Colorectal Neoplasms

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