Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

NCT ID: NCT00309543

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

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fluorouracil

Intervention Type DRUG

Leucovorin

Intervention Type DRUG

Eligibility Criteria

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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
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

Hospital Hainburg

Hainburg an der Donau, Lower Austria, Austria

Site Status

Hospital Krems

Krems, Lower Austria, Austria

Site Status

Hospital Tulln

Tulln, Lower Austria, Austria

Site Status

Hospital Waidhofen/Thaya

Waidhofen A. D. Thaya, Lower Austria, Austria

Site Status

Hospital Wiener Neustadt, Surgery

Wiener Neustadt, Lower Austria, 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

Leoben, Styria, Austria

Site Status

Hospital St. Vinzenz

Zams, Tyrol, Austria

Site Status

State Hospital Kirchdorf

Kirchdorf, 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 91

Identifier Type: -

Identifier Source: org_study_id