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Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00309543
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group

Tracking Information
First Submitted Date  ICMJE March 31, 2006
First Posted Date  ICMJE April 3, 2006
Last Update Posted Date April 3, 2006
Study Start Date  ICMJE November 1993
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2006)
Overall survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
Official Title  ICMJE A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer Stage II
Intervention  ICMJE
  • Drug: Fluorouracil
  • Drug: Leucovorin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 31, 2006)
636
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00309543
Other Study ID Numbers  ICMJE ABCSG 91
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Austrian Breast & Colorectal Cancer Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
PRS Account Austrian Breast & Colorectal Cancer Study Group
Verification Date March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP