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).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 8
- 主要终点
- Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis histologically confirmed of renal cells carcinoma (every histotype);
- •Age < 75 years
- •Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months
- •Patient classified as T1 (with diameter > 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy
- •Absence of distant metastases;
- •Written informed consent
排除标准
- •Tumor diameter equal or less than 2,5 cm;
- •Previous chemotherapy or ormonotherapy o immunotherapy;
- •Renal insufficiency >3 mg/dl);
- •No symptomatic arrhythmias or autoimmune disease
研究组 & 干预措施
A-immunotherapy
Immunotherapy with interferon-alpha and interleukin
干预措施: Interferon Alfa-2a (Drug)
A-immunotherapy
Immunotherapy with interferon-alpha and interleukin
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.
次要结局
- Tolerability, toxicity and safety.