Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
1 other identifier
interventional
636
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1993
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedApril 3, 2006
March 1, 2006
March 31, 2006
March 31, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hospital Guessing
Güssing, Burgenland, 7540, Austria
Hospital Oberpullendorf
Oberpullendorf, Burgenland, 7350, Austria
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, 9330, Austria
State Hospital Wolfsberg
Wolfsberg, Carinthia, 9400, Austria
Hospital Hainburg
Hainburg an der Donau, Lower Austria, 2410, Austria
Hospital Krems
Krems, Lower Austria, 3500, Austria
Hospital Tulln
Tulln, Lower Austria, 3430, Austria
Hospital Waidhofen/Thaya
Waidhofen A. D. Thaya, Lower Austria, 3830, Austria
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, 2700, Austria
Paracelsus Medical University Salzburg - Oncology
Salzburg, Salzburg, 5020, Austria
Medical University of Graz, Oncology
Graz, Styria, 8036, Austria
State Hospital Leoben
Leoben, Styria, 8700, Austria
Hospital St. Vinzenz
Zams, Tyrol, 6511, Austria
State Hospital Kirchdorf
Kirchdorf, Upper Austria, 4560, Austria
Hospital Kreuzschwestern Wels
Wels, Upper Austria, 4600, Austria
Medical University Vienna, General Hospital
Vienna, Vienna, 1090, Austria
Wilheminenspital, Internal Medicin I
Vienna, Vienna, 1160, Austria
State Hospital Feldkirch
Feldkirch, Vorarlberg, 6807, Austria
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raimund Jakesz, MD
Austrian Breast & Colorectal Cancer Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
November 1, 1993
Last Updated
April 3, 2006
Record last verified: 2006-03