Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Austrian Breast & Colorectal Cancer Study Group636 enrolled

Overview

This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

636

Conditions

Colon Cancer Stage II

Interventions

FluorouracilDRUG

LeucovorinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (18)

Hospital Guessing

Güssing, Burgenland, Austria

Hospital Oberpullendorf

Oberpullendorf, Burgenland, Austria

Outcomes

Primary Outcomes

Overall survival

Data from ClinicalTrials.gov

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