NCT00301782已完成2 期
Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 40
- 主要终点
- Response rates to treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating germ cell tumors.
PURPOSE: This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating male patients with germ cell tumors.
详细描述
OBJECTIVES:
Primary
- Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ cell tumors treated with intensive induction chemotherapy comprising cisplatin, vincristine, bleomycin, and carboplatin followed by bleomycin, etoposide phosphate, and cisplatin (BEP) vs standard BEP chemotherapy.
Secondary
- Compare overall and progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods:
- •Histologic confirmation
- •Alpha-fetoprotein (AFP) > 1,000 ng/mL or human chorionic gonadotropin (hCG) > 5,000 IU/L with appropriate clinical picture in a man < 45 years of age
- •Poor prognosis features as defined by ≥ 1 of the following:
- •AFP > 10,000 ng/mL
- •hCG > 50,000 IU/L
- •Lactic dehydrogenase > 10 times normal
- •Nonpulmonary visceral metastases
- •Mediastinal primary site
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-3
- •Glomerular filtration rate > 50 mL/min
- •Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy
- •No comorbid condition that would prevent treatment
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy
排除标准
- 未提供
结局指标
主要结局
Response rates to treatment
次要结局
- Overall survival
- Progression-free survival
- Toxicity
研究者
研究点 (40)
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