NCT00324298已完成3 期
A Randomized Phase III Toxicity Study of Day 2, 3, 8, 15 Short (30 Minute) Versus Day 1, 2, 3 Long (72 Hours) Infusion Bleomycin for Patients With IGCCCG Good Prognosis Germ Cell Tumors, TE3
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 20
- 主要终点
- Pulmonary toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, 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 schedule of bleomycin is more effective when given together with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.
PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with etoposide and cisplatin in treating patients with metastatic germ cell cancer of the testicles.
详细描述
OBJECTIVES:
Primary
- Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin, etoposide, and cisplatin for good-prognosis, metastatic germ cell cancer of the testes.
- Determine if early lung function tests are a predictor for late toxicity.
- Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation.
- Validate the O'Sullivan et al prognostic scoring system for bleomycin toxicity.
Secondary
- Determine response to treatment.
- Determine progression-free survival and overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pulmonary toxicity
次要结局
- Progression-free survival
- Overall survival
- Response to treatment
研究者
研究点 (20)
Loading locations...
相似试验
已完成
3 期
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung CancerLung CancerNCT00433498University College, London846
已完成
3 期
High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade GliomasCentral Nervous System TumorBrain TumorNCT00078988Children's Oncology Group1
已完成
2 期
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone TherapyProstate CancerNCT00627354Groupe D'Etude des Tumeurs Uro-Genitales90
已完成
3 期
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical HysterectomyCervical CancerNCT00980954Radiation Therapy Oncology Group236
已完成
不适用
Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung CancerLung CancerNCT00433563The Christie NHS Foundation Trust547