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A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).


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

Thank you

Trial Information

A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).


Inclusion Criteria:



- Patients with histologically verified, curatively operated colon carcinoma Stage III
(R0, T1-4, N1-3, M0)

- Age: less than 80 years

- WHO Performace Status > 2

- Adequate bone marrow reserve

- Informed consent

Exclusion Criteria:

- Rectal cancer

- R1, R2, carcinosis peritonei

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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Recurrence-free 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 90

NCT ID:

NCT00309530

Start Date:

October 1990

Completion Date:

Related Keywords:

  • Colon Cancer Stage III
  • Fluorouracil
  • Levamisol
  • Interferon
  • Colon cancer
  • Carcinoma
  • Colonic Neoplasms

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