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

Primary Purpose

Colon Cancer Stage III

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
5-fluorouracil, levamisol, interferon
Sponsored by
Austrian Breast & Colorectal Cancer Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer Stage III focused on measuring Fluorouracil, Levamisol, Interferon, Colon cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Guessing
  • Hospital Oberpullendorf
  • Hospital BHB St. Veit/Glan, Surgery
  • State Hospital Wolfsberg
  • Medical University of Graz, Oncology
  • State Hospital Leoben, Surgery
  • Hospital St. Vinzenz
  • State Hospital Kirchdorf
  • General Hospital Linz
  • Hospital BHB Linz
  • State Hospital Voecklabruck, Internal Medicine
  • Hospital Kreuzschwestern Wels
  • State Hospital Feldkirch
  • Paracelsus Medical University Salzburg - Oncology
  • Medical University Vienna, General Hospital
  • Wilheminenspital, Internal Medicin I

Outcomes

Primary Outcome Measures

Recurrence-free survival
Overall survival

Secondary Outcome Measures

Full Information

First Posted
March 31, 2006
Last Updated
March 31, 2006
Sponsor
Austrian Breast & Colorectal Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00309530
Brief Title
Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
October 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Austrian Breast & Colorectal Cancer Study Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage III
Keywords
Fluorouracil, Levamisol, Interferon, Colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
598 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
5-fluorouracil, levamisol, interferon
Primary Outcome Measure Information:
Title
Recurrence-free survival
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimund Jakesz, MD
Organizational Affiliation
Austrian Breast & Colorectal Cancer Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Guessing
City
Guessing
State/Province
Burgenland
ZIP/Postal Code
7540
Country
Austria
Facility Name
Hospital Oberpullendorf
City
Oberpullendorf
State/Province
Burgenland
ZIP/Postal Code
7350
Country
Austria
Facility Name
Hospital BHB St. Veit/Glan, Surgery
City
St. Veit a. d. Glan
State/Province
Carinthia
ZIP/Postal Code
9330
Country
Austria
Facility Name
State Hospital Wolfsberg
City
Wolfsberg
State/Province
Carinthia
ZIP/Postal Code
9400
Country
Austria
Facility Name
Medical University of Graz, Oncology
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
State Hospital Leoben, Surgery
City
Leoben
State/Province
Styria
ZIP/Postal Code
8700
Country
Austria
Facility Name
Hospital St. Vinzenz
City
Zams
State/Province
Tyrol
ZIP/Postal Code
6511
Country
Austria
Facility Name
State Hospital Kirchdorf
City
Kirchdorf
State/Province
Upper Austria
ZIP/Postal Code
4560
Country
Austria
Facility Name
General Hospital Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
Hospital BHB Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Facility Name
State Hospital Voecklabruck, Internal Medicine
City
Voecklabruck
State/Province
Upper Austria
ZIP/Postal Code
4840
Country
Austria
Facility Name
Hospital Kreuzschwestern Wels
City
Wels
State/Province
Upper Austria
ZIP/Postal Code
4600
Country
Austria
Facility Name
State Hospital Feldkirch
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
Facility Name
Paracelsus Medical University Salzburg - Oncology
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medical University Vienna, General Hospital
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilheminenspital, Internal Medicin I
City
Vienna
ZIP/Postal Code
1160
Country
Austria

12. IPD Sharing Statement

Links:
URL
http://www.abcsg.at
Description
Related Info

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

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