Carcinoma, Renal Cell Clinical Trial
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).
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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