Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
研究概览
简要总结
The purpose of this study is to determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical or Histological diagnosis of germ cell tumors
- •Metastatic disease
- •Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
- •No prior chemotherapy for metastatic disease
排除标准
- •Unwillingness to accomplish the study procedures
- •Any existing co-morbidity that could limit the administration of high dose chemotherapy
- •Any psychiatric disorder that could impact on the study compliance
研究组 & 干预措施
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
干预措施: Bleomycin (Drug)
High dose chemotherapy
Characterized by the following sequence:
High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin
1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
干预措施: Cyclophosphamide (Drug)
High dose chemotherapy
Characterized by the following sequence:
High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin
1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
干预措施: Etoposide (Drug)
High dose chemotherapy
Characterized by the following sequence:
High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin
1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
干预措施: Cisplatin (Drug)
High dose chemotherapy
Characterized by the following sequence:
High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin
1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
干预措施: Carboplatin (Drug)
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
干预措施: Etoposide (Drug)
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
干预措施: Cisplatin (Drug)
结局指标
主要结局
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
时间窗: 5 years
次要结局
- Overall survival(5 years)
研究者
Andrea Necchi
Faculty, Department of Medical Oncology
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano