Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
This study has been completed.
Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309530
First received: March 31, 2006
Last updated: NA
Last verified: April 1999
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer Stage III |
Drug: 5-fluorouracil, levamisol, interferon |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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). |
Resource links provided by NLM:
Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309530
Locations
| Austria | |
| Hospital Guessing | |
| Guessing, Burgenland, Austria, 7540 | |
| Hospital Oberpullendorf | |
| Oberpullendorf, Burgenland, Austria, 7350 | |
| Hospital BHB St. Veit/Glan, Surgery | |
| St. Veit a. d. Glan, Carinthia, Austria, 9330 | |
| State Hospital Wolfsberg | |
| Wolfsberg, Carinthia, Austria, 9400 | |
| Medical University of Graz, Oncology | |
| Graz, Styria, Austria, 8036 | |
| State Hospital Leoben, Surgery | |
| Leoben, Styria, Austria, 8700 | |
| Hospital St. Vinzenz | |
| Zams, Tyrol, Austria, 6511 | |
| State Hospital Kirchdorf | |
| Kirchdorf, Upper Austria, Austria, 4560 | |
| General Hospital Linz | |
| Linz, Upper Austria, Austria, 4020 | |
| Hospital BHB Linz | |
| Linz, Upper Austria, Austria, 4020 | |
| State Hospital Voecklabruck, Internal Medicine | |
| Voecklabruck, Upper Austria, Austria, 4840 | |
| Hospital Kreuzschwestern Wels | |
| Wels, Upper Austria, Austria, 4600 | |
| State Hospital Feldkirch | |
| Feldkirch, Vorarlberg, Austria, 6807 | |
| Paracelsus Medical University Salzburg - Oncology | |
| Salzburg, Austria, 5020 | |
| Wilheminenspital, Internal Medicin I | |
| Vienna, Austria, 1160 | |
| Medical University Vienna, General Hospital | |
| Vienna, Austria, 1090 | |
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Investigators
| Principal Investigator: | Raimund Jakesz, MD | Austrian Breast & Colorectal Cancer Study Group |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00309530 History of Changes |
| Other Study ID Numbers: | ABCSG 90 |
| Study First Received: | March 31, 2006 |
| Last Updated: | March 31, 2006 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
|
Fluorouracil Levamisol Interferon Colon cancer |
Additional relevant MeSH terms:
|
Carcinoma Colonic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Adjuvants, Immunologic Fluorouracil Interferons Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013