Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

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.

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Key information

Conditions

Colon Cancer Stage II Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Guessing, Guessing, Burgenland, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil

Drug

Leucovorin

Drug

Primary outcomes

Overall survival

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Registry information

Official study title

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

Important dates

Study start: 1993
First posted: Apr 3, 2006
Registry last updated: Apr 3, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed