Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309543

Enrollment

636

Registered

2006-04-03

Start date

1993-11-30

Completion date

Unknown

Last updated

2006-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer Stage II

Keywords

Fluorouracil, Leucovorin, Colon cancer

Brief summary

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.

Interventions

DRUGFluorouracil

DRUGLeucovorin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026