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Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer Clinical research trials and Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer. Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer  Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
For Condition: stage 4 renal cell cancer,stage 3 renal cell cancer
Status: No longer recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group , Cancer Research UK Clinical Trials Unit at the University of Glasgow
Synopsis: 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.
Details: OBJECTIVES: - Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8. - Arm II (control arm): Patients receive no adjuvant treatment before disease progression. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria: - Stage T3b, T3c, or T4 tumor - Any pT stage and nodal status pN 1 or 2 - Any pT stage and microscopic positive margins - Presence of any microscopic vascular invasion - Underwent surgical resection of primary tumor within the past month - Removal of clinical N+ disease required - No evidence of metastatic disease - No evidence of macroscopic residual disease PATIENT CHARACTERISTICS: Age - 75 and under Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Liver function tests no greater than 1.25 times upper limit of normal (ULN) Renal - Creatinine less than 1.5 times ULN Cardiovascular - No myocardial infarction within the past 6 months - No unstable angina pectoris Other - Not pregnant or nursing - No prior or other concurrent malignancies that would preclude study therapy or comparisons - No other concurrent illness that would preclude study therapy - No concurrent active infections requiring antibiotic therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent immunotherapy Chemotherapy - No prior chemotherapy Endocrine therapy - No concurrent corticosteroids - No concurrent hormonal therapy Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics - No prior major organ allografts Other - No other concurrent investigational drugs, agents, or devices
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeinPoppel, , U.Z. Gasthuisberg
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Jeroen Bosch Ziekenhuis
Hertogenbosch, , 5211 NL
Netherlands
National Institute of Oncology
Budapest, , 1125
Hungary
Ospedale di Circolo e Fondazione Macchi
Varese, , 21100
Italy
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, , 3075 EA
Netherlands
Universitair Ziekenhuis Gent
Ghent, , B-9000
Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , B-9300
Belgium
Marmara University Hospital
Istanbul, , 81190
Turkey
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Dokuz Eylul University School of Medicine
Izmir, , 35340
Turkey
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 HA
Netherlands
AZ Groeninge - Campus St. Maarten
Kortrijk, , 8500
Belgium
Beatson Institute for Cancer Research - Glasgow
Glasgow, Scotland, G61 1BD
United Kingdom
University Medical Center Nijmegen
Nijmegen, , 6500 HB
Netherlands
Akademisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Rambam Medical Center
Haifa, , 30196
Israel
Additional Information:
Study ID Numbers: CDR0000269479; EORTC-30955
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053807
Other Stage 4 Renal Cell Cancer Studies:
1. Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
2. Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
3. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
4. PEG-Interferon alfa-2b in Treating Patients With Metastatic Kidney Cancer
5. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Clinical Trials
Other Hertogenbosch Clinical Trials
Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
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