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A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).


Phase 3
18 Years
80 Years
Not Enrolling
Both
Colon Cancer Stage II

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Trial Information

A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).


Inclusion Criteria:



- Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4,
N0, M0)

- Age: less than 80 years

- WHO Performance > 2

- Adequate bone marrow reserve, renal and hepatic functions

- Informed consent

Exclusion Criteria:

- Rectal cancer

- R1or R2 resection; carcinosis peritonei

- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or
immunotherapy

- Serious concomitant disease, in particular chronically inflammatory large intestine,
cardiopathic or metabolic disease, malignant second carcinoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Raimund Jakesz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

ABCSG 91

NCT ID:

NCT00309543

Start Date:

November 1993

Completion Date:

Related Keywords:

  • Colon Cancer Stage II
  • Fluorouracil
  • Leucovorin
  • Colon cancer
  • Carcinoma
  • Colonic Neoplasms

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