Randomized, Multicenter Phase III Trial Comparing Adjuvant Treatment With PegIntron Over 36 Months Versus Reference Treatment With IntronA Over 18 Months in Cutaneous Melanoma Patients AJCC Stage II (>=1.5 mm Clinically Node Negative)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 898
- 试验地点
- 1
- 主要终点
- disease-free survival time
研究概览
简要总结
Melanoma with a tumor thickness >= 1.5mm without clinically detectable nodes represents an increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of IFN alpha can provide a benefit in this group. However, the impact of low dose IFN alpha is not sustained after the treatment period. A longer treatment may prolong the benefit and thus have a more clear-cut impact on disease-free and overall survival. The tolerance and the impact on quality of life are limiting factors in a group of patients whose individual course is not necessarily poor. PegIntron may be better tolerated than instant release interferon, and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus treatment schedule with PegIntron is not expected to increase the cost of standard care significantly.
详细描述
Study design and primary objective
This is an European multicenter, open label, prospective randomized phase III trial evaluating the efficacy of long-term maintenance therapy of two therapy options, IntronA for 18 months versus PegIntron for 36 months, administered in an adjuvant setting after the local excision of an intermediate risk cutaneous melanoma.
Eligibility criteria
Intermediate risk melanoma is defined by the following criteria: (1) a tumor thickness >= 1,5mm and (2) the absence of regional nodal macrometastases, as assessed either by clinical examination or, if sentinel lymph node biopsy (SLNB) or elective node dissection (ELND) are performed, by the absence of macroscopic evidence of disease. Patients with evidence of nodal micrometastasis by SLNB or ELND are eligible. The choice of performing sentinel node dissection will be left to the decision of each center, on condition to concern all consecutive patients and that all surgical procedures are completed before randomization of the patients . The centers have to inform their respective national study center if they perform SLNB or ELND and also if they change their surgical procedure.
Study treatments
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
- •Histologically proven cutaneous melanoma
- •Tumour thickness >= 1.5 mm (Breslow staging)
- •Absence of clinically detectable regional node metastasis, no evidence of distant metastasis
- •Informed consent form signed
排除标准
- •Any prior chemo-, immuno-, hormonal or radiation therapy
- •Macroscopic disease
研究组 & 干预措施
A
Peg Intron 100 mcg SC/week for 36 months
干预措施: PegIntron (Drug)
B
Intron A 3 X 3 MIU, weekly, sc, for 18 months
干预措施: intron A (Drug)
结局指标
主要结局
disease-free survival time
时间窗: 5-year
次要结局
- time to distant metastasis(the time from the inclusion to the first documentation of any distant metastasis)
- overall survival(the time from the inclusion to the date of death regardless of the specific cause)
- toxicity(for 36 months)
- quality of life(36 months)