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Sponsored by: |
Gruppo Oncologico Italiano di Ricerca Clinica |
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Information provided by: | Gruppo Oncologico Italiano di Ricerca Clinica |
ClinicalTrials.gov Identifier: | NCT00502034 |
The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Drug: Interleukin 2 Drug: Interferon-alpha2 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Adjuvant Low-Dose Interleukin-2 (IL2) Plus Interferone-Alpha (IFN) in Operable Renal Cell Cancer (RCC). Phase III, Randomized, Multicenter Trial of the Italian Oncology Group for Clinical Research (GOIRC). |
Enrollment: | 310 |
Study Start Date: | July 1994 |
For pts with non-metastatic RCC, no standard adjuvant treatment exists. Immunotherapy (IT) using IFN and/or IL2 is effective in metastatic disease setting. Low and chronically repeated doses of IL2 plus IFN induce a persistent stimulation of the immune system with no relevant toxicity. Surgically treated RCC pts were randomized to the following arms: A) low-dose IT; B) control arm. IT consisted of a 4-week cycle of s.c. IL2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1 million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 of each week). Cycles were repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years. Each patient received 12 cycles in 5 years. Inclusion criteria were as follows: histological diagnosis of RCC, age <75 yrs, radical or partial nephrectomy within the past 3 months, pT1 (diameter of T > 2,5 cm), T2, T3 a-b-c; pN0-pN3, M0; good cardiac and renal function and no autoimmune disease.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Parma University Hospital | |
Parma, Italy, 43100 | |
Arcispedale Santa Maria Nuova | |
Reggio Emilia, Italy, 42100 | |
Modena University Hospital | |
Modena, Italy, 41100 | |
Pavia University Hospital | |
Pavia, Italy, 27100 | |
Ospedali Riuniti di Bergamo | |
Bergamo, Italy, 24128 | |
Ospedale "Guglielmo da Saliceto" | |
Piacenza, Italy, 29100 | |
Istituti Ospitalieri di Cremona | |
Cremona, Italy, 26100 | |
Parma University Hospital | |
Parma, Italy, 43100 | |
Italy, Modena | |
Carpi Hospital | |
Carpi, Modena, Italy, 41012 |
Study Chair: | Rodolfo Passalacqua, Medicine | Gruppo Oncologico Italiano di Ricerca Clinica |
Study Chair: | Carlo Buzio, Medicine | Parma University |
Study ID Numbers: | POLAR 01 |
Study First Received: | July 16, 2007 |
Last Updated: | July 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00502034 History of Changes |
Health Authority: | Italy: Ministry of Health |
Carcinoma, Renal Cell Low-dose Interleukin Adjuvant Immunotherapy |
Interferon-alpha Anti-Infective Agents Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Interferons Adjuvants, Immunologic Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Antiviral Agents Carcinoma |
Renal Cancer Urologic Diseases Analgesics, Non-Narcotic Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Peripheral Nervous System Agents Analgesics Kidney Diseases Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Sensory System Agents Kidney Neoplasms Therapeutic Uses Analgesics Kidney Diseases Angiogenesis Modulating Agents Growth Inhibitors |
Interferon-alpha Neoplasms by Histologic Type Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Interleukin-2 Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Interferon Alfa-2a Central Nervous System Agents |