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

NCT ID: NCT00309530

Last Updated: 2006-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Stage III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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5-fluorouracil, levamisol, interferon

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austrian Breast & Colorectal Cancer Study Group

NETWORK

Sponsor Role lead

Principal Investigators

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Raimund Jakesz, MD

Role: PRINCIPAL_INVESTIGATOR

Austrian Breast & Colorectal Cancer Study Group

Locations

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Hospital Guessing

Güssing, Burgenland, Austria

Site Status

Hospital Oberpullendorf

Oberpullendorf, Burgenland, Austria

Site Status

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, Austria

Site Status

State Hospital Wolfsberg

Wolfsberg, Carinthia, Austria

Site Status

Paracelsus Medical University Salzburg - Oncology

Salzburg, Salzburg, Austria

Site Status

Medical University of Graz, Oncology

Graz, Styria, Austria

Site Status

State Hospital Leoben, Surgery

Leoben, Styria, Austria

Site Status

Hospital St. Vinzenz

Zams, Tyrol, Austria

Site Status

State Hospital Kirchdorf

Kirchdorf, Upper Austria, Austria

Site Status

General Hospital Linz

Linz, Upper Austria, Austria

Site Status

Hospital BHB Linz

Linz, Upper Austria, Austria

Site Status

State Hospital Voecklabruck, Internal Medicine

Vöcklabruck, Upper Austria, Austria

Site Status

Hospital Kreuzschwestern Wels

Wels, Upper Austria, Austria

Site Status

Medical University Vienna, General Hospital

Vienna, Vienna, Austria

Site Status

Wilheminenspital, Internal Medicin I

Vienna, Vienna, Austria

Site Status

State Hospital Feldkirch

Feldkirch, Vorarlberg, Austria

Site Status

Countries

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Austria

Related Links

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Other Identifiers

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ABCSG 90

Identifier Type: -

Identifier Source: org_study_id