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临床试验/NCT00002472
NCT00002472已完成2 期

Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies

Mayo Clinic6 个研究点 分布在 1 个国家开始时间: 1991年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Mayo Clinic
试验地点
6
主要终点
Response rate

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.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating patients with CNS tumors.

详细描述

OBJECTIVES:

  • Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide.
  • Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy.
  • Determine endocrine and cognitive function in these patients before and after receiving this regimen.

OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma).

Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses, if feasible, and then proceed to radiotherapy. Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy.

Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on histology, extent of disease, and response to chemotherapy. Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Response rate

Survival

Endocrine and cognitive function

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (6)

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