Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.
|Carcinoma, Renal Cell||Drug: Interferon Alfa-2a Drug: Interleukin-2||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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).|
- Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.
- Tolerability, toxicity and safety.
|Study Start Date:||July 1994|
|Study Completion Date:||June 2012|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Immunotherapy with interferon-alpha and interleukin
Drug: Interferon Alfa-2a
Interferon Alfa-2a in combination with InterleukinDrug: Interleukin-2
Interferon Alfa-2a in combination with Interleukin
No Intervention: B-follow-up
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502034
|Carpi, Modena, Italy, 41012|
|Ospedali Riuniti di Bergamo|
|Bergamo, Italy, 24128|
|Istituti Ospitalieri di Cremona|
|Cremona, Italy, 26100|
|Modena University Hospital|
|Modena, Italy, 41100|
|Parma University Hospital|
|Parma, Italy, 43100|
|Pavia University Hospital|
|Pavia, Italy, 27100|
|Ospedale "Guglielmo da Saliceto"|
|Piacenza, Italy, 29100|
|Arcispedale Santa Maria Nuova|
|Reggio Emilia, Italy, 42100|
|Study Chair:||Rodolfo Passalacqua, Medicine||Gruppo Oncologico Italiano di Ricerca Clinica|
|Study Chair:||Carlo Buzio, Medicine||Parma University|