NCT00003643Unknown2 期
Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
European Organisation for Research and Treatment of Cancer - EORTC138 个研究点 分布在 13 个国家目标入组 498 人开始时间: 1998年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 498
- 试验地点
- 138
- 主要终点
- Failure-free survival as measured by Logrank
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.
PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
详细描述
OBJECTIVES:
Phase II
- Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
- Define the toxicity profile of T-BEP in these patients.
Phase III
- Compare the disease-free survival of patients treated with these regimens.
- Compare the complete response rates and overall survival of patients treated with these regimens.
- Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
- Compare the acute and intermediate (1-2 years) side effects 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
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven germ cell cancer
- •Non-seminoma
- •Intermediate prognosis
- •Non-seminoma:
- •Testis/retroperitoneal primary
- •No non-pulmonary visceral metastases
- •Meets 1 of the following criteria:
- •Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L
- •Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L
- •Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN)
- •Seminoma:
- •Any primary site
- •Any LDH and HCG
- •AFP normal
- •Non-pulmonary visceral metastases present
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 times ULN
- •AST no greater than 2 times ULN
- •Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy)
- •No pre-existing neuropathy
- •No other malignancy except basal cell skin cancer
- •No other serious illness or medical conditions incompatible with the protocol
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Failure-free survival as measured by Logrank
次要结局
- Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
- Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
研究者
研究点 (138)
Loading locations...
相似试验
已完成
2 期
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung CancerLung CancerNCT00006378Case Comprehensive Cancer Center5
Unknown
2 期
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck CancerHead and Neck CancerNCT00003327Theradex60
Unknown
2 期
Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the EsophagusEsophageal CancerNCT00003326Theradex100
Unknown
2 期
Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and PlatinumFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00003160Theradex100
已完成
2 期
Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast CancerBreast CancerNCT00003539Memorial Sloan Kettering Cancer Center50