Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
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).
1 other identifier
interventional
598
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
16 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
October 1, 1990
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedApril 3, 2006
April 1, 1999
March 31, 2006
March 31, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recurrence-free survival
Overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Paracelsus Medical University Salzburg - Oncology
Salzburg, Salzburg, 5020, Austria
Medical University of Graz, Oncology
Graz, Styria, 8036, Austria
State Hospital Leoben, Surgery
Leoben, Styria, 8700, Austria
Hospital St. Vinzenz
Zams, Tyrol, 6511, Austria
State Hospital Kirchdorf
Kirchdorf, Upper Austria, 4560, Austria
General Hospital Linz
Linz, Upper Austria, 4020, Austria
Hospital BHB Linz
Linz, Upper Austria, 4020, Austria
State Hospital Voecklabruck, Internal Medicine
Vöcklabruck, Upper Austria, 4840, 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
- FACTORIAL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
October 1, 1990
Last Updated
April 3, 2006
Record last verified: 1999-04