Viewing Study NCT00502034



Ignite Creation Date: 2024-05-05 @ 6:34 PM
Last Modification Date: 2024-10-26 @ 9:34 AM
Study NCT ID: NCT00502034
Status: COMPLETED
Last Update Posted: 2013-07-10
First Post: 2007-07-16

Brief Title: Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
Organization: Gruppo Oncologico Italiano di Ricerca Clinica

Study Overview

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
Status: COMPLETED
Status Verified Date: 2013-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: For pts with non-metastatic RCC no standard adjuvant treatment exists Immunotherapy IT using IFN andor 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 sc IL2 5 dayswk 1 million UIsqm bid d 12 and 1 million UIsqm x 1 d 345 IFN 18 million UIsqm d 35 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 25 cm T2 T3 a-b-c pN0-pN3 M0 good cardiac and renal function and no autoimmune disease

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None