Germ Cell Tumour Study II
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 43
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, 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. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain.
PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.
详细描述
OBJECTIVES:
- Determine the toxic effects of etoposide, carboplatin, and bleomycin in young patients with malignant germ cell tumors.
OUTLINE: Patients are assigned to one of two treatment arms based on their tumor type (testicular vs ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic).
- Group 1 (testicular tumors): Patients undergo radical orchiectomy. Patients with stage I tumors and alpha-fetoprotein (AFP) decreasing at the expected rate receive no further treatment unless there is a subsequent rise in the AFP or a clinical recurrence. Patients with stage II-IV tumors receive etoposide IV over 1 hour on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 15 minutes on day 3. Treatment repeats every 21- 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Residual teratoma may be removed, if indicated, after completion of chemotherapy.
- Group 2 (ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic germ cell tumors): Patients undergo surgical removal or biopsy of the tumor. Patients then receive etoposide, carboplatin, and bleomycin as above. Patients may then undergo further surgery at the discretion of the principal investigator.
After completion of study treatment, patients are followed periodically.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven malignant germ cell tumors at all stages
- •Testicular tumors
- •Stage I - Confined to testes
- •Stage II - Confined to testes and retroperitoneal/abdominal lymph nodes
- •Stage III - Supradiaphragmatic nodal disease (mediastinal and/or supraclavicular)
- •Stage IV - Extralymphatic spread (liver, lung, bone, brain, skin, etc.)
- •Ovarian, uterine, vaginal, and sacrococcygeal tumors
- •Stage I - Confined to ovary/uterus/vagina/pre- and postsacral area
- •Stage II - Spread limited to the pelvis
- •Stage III - Spread limited to the abdomen (excluding liver)
- •Stage IV - Spread to liver or beyond the abdominal cavity
- •Abdominal, retroperitoneal, and thoracic primary tumors
- •Stage I - Confined to site of origin and resectable
- •Stage II - Local spread
- •Stage III - Extensive spread confined to one side of the diaphragm (excluding the liver)
- •Stage IV - Tumor spread to the liver, to both sides of the diaphragm, and/or to bones, bone marrow, brain, etc.
- •Intracranial germ cell tumor cases allowed even if an alternative protocol is being followed
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy
排除标准
- 未提供