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Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Primary Purpose

Colon Cancer Stage II

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Fluorouracil
Leucovorin
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 II focused on measuring Fluorouracil, Leucovorin, Colon cancer

Eligibility Criteria

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

Sites / Locations

  • Hospital Guessing
  • Hospital Oberpullendorf
  • Hospital BHB St. Veit/Glan, Surgery
  • State Hospital Wolfsberg
  • Hospital Hainburg
  • Hospital Krems
  • Hospital Tulln
  • Hospital Waidhofen/Thaya
  • Hospital Wiener Neustadt, Surgery
  • Medical University of Graz, Oncology
  • State Hospital Leoben
  • Hospital St. Vinzenz
  • State Hospital Kirchdorf
  • Hospital Kreuzschwestern Wels
  • State Hospital Feldkirch
  • Paracelsus Medical University Salzburg - Oncology
  • Medical University Vienna, General Hospital
  • Wilheminenspital, Internal Medicin I

Outcomes

Primary Outcome Measures

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
NCT00309543
Brief Title
Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
Official Title
A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
November 1993 (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 influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage II
Keywords
Fluorouracil, Leucovorin, Colon cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Primary Outcome Measure Information:
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, 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
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
Hospital Hainburg
City
Hainburg
State/Province
Lower Austria
ZIP/Postal Code
2410
Country
Austria
Facility Name
Hospital Krems
City
Krems
State/Province
Lower Austria
ZIP/Postal Code
3500
Country
Austria
Facility Name
Hospital Tulln
City
Tulln
State/Province
Lower Austria
ZIP/Postal Code
3430
Country
Austria
Facility Name
Hospital Waidhofen/Thaya
City
Waidhofen a. d. Thaya
State/Province
Lower Austria
ZIP/Postal Code
3830
Country
Austria
Facility Name
Hospital Wiener Neustadt, Surgery
City
Wiener Neustadt
State/Province
Lower Austria
ZIP/Postal Code
2700
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
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
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 Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

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