Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C

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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309530

Enrollment

598

Registered

2006-04-03

Start date

1990-10-31

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 III

Keywords

Fluorouracil, Levamisol, Interferon, Colon cancer

Brief summary

This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.

Interventions

DRUG5-fluorouracil, levamisol, interferon

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival	—
Overall survival	—

Countries

Austria

Outcome results

None listed

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