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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Collaborator: |
University of Glasgow |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053807 |
Purpose
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin Biological: recombinant interferon alfa Drug: fluorouracil Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma |
| Study Start Date: | February 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and at 2 and 6 months after randomization.
Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:
Underwent surgical resection of primary tumor within the past month
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna, Austria, A-1100 | |
| Belgium | |
| Onze Lieve Vrouw Ziekenhuis Aalst | |
| Aalst, Belgium, B-9300 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| AZ Groeninge - Campus St. Maarten | |
| Kortrijk, Belgium, 8500 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1125 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 30196 | |
| Italy | |
| Ospedale di Circolo e Fondazione Macchi | |
| Varese, Italy, 21100 | |
| Netherlands | |
| Akademisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Jeroen Bosch Ziekenhuis | |
| Hertogenbosch, Netherlands, 5211 NL | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, 6500 HB | |
| Daniel Den Hoed Cancer Center at Erasmus University Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Turkey | |
| Marmara University Hospital | |
| Istanbul, Turkey, 81190 | |
| Dokuz Eylul University School of Medicine | |
| Izmir, Turkey, 35340 | |
| United Kingdom | |
| Beatson Institute for Cancer Research - Glasgow | |
| Glasgow, Scotland, United Kingdom, G61 1BD | |
| Investigator: | Pieter H. M. de Mulder, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
| Investigator: | Hein van Poppel, MD, PhD | U.Z. Gasthuisberg |
| Investigator: | Paul A. Vasey, MD | Beatson Institute for Cancer Research - Glasgow |
More Information
| ClinicalTrials.gov Identifier: | NCT00053807 History of Changes |
| Other Study ID Numbers: | CDR0000269479, EORTC-30955 |
| Study First Received: | February 5, 2003 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Federal Government |
|
stage III renal cell cancer stage IV renal cell cancer |
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Adjuvants, Immunologic Interferon-alpha Interferon Alfa-2a |
Interferons Aldesleukin Fluorouracil Interleukin-2 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |