Clinical trial · Interventional
Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aldesleukin | Biological | Aldesleukin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAitchison M, Bray CA, Van Poppel H, et al.: Final results from an EORTC (GU Group)/NCRI randomized phase III trial of adjuvant interleukin-2, interferon alpha, and 5-fluorouracil in patients with a high risk of relapse after nephrectomy for renal cell carcinoma (RCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-4505, 2011.