NCT00293358已完成3 期
SIOP Intracranial Germ Cell Tumours Protocol
Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 500 人开始时间: 1997年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 41
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain.
详细描述
OBJECTIVES:
Primary
- Evaluate and compare, in a non-randomized protocol, reduced-dose craniospinal radiotherapy alone or combination chemotherapy comprising carboplatin, etoposide phosphate, and ifosfamide and local irradiation in patients with intracranial germinoma.
- Increase survival with combination chemotherapy comprising cisplatin, etoposide phosphate, and ifosfamide followed by focal radiotherapy or craniospinal irradiation in patients with intracranial secreting germ cell tumors.
Secondary
- Use the same diagnostic protocol for imaging and laboratory investigations before, during, and after treatment.
- Establish and use a common documentation system regarding general patient's data, including diagnostic tests, clinical evaluation, surgery, histology, radiotherapy, chemotherapy, and toxicity.
- Collect information about toxicity, prognostic factors, and tumor markers.
- Collect epidemiological data, including documentation of incidence and the site and the histologic pattern of intracranial secreting and nonsecreting germ cell tumors in children and adolescents.
- Register associated malformations in the patients as well as the epidemiology of tumors and malformations in relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:
- •Germinoma
- •Pure germinoma
- •Germinoma with mature and/or immature teratoma
- •Secreting germ cell tumor
- •Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:
- •Alpha-fetoprotein > 25 ng/mL
- •β-human choriogonadotropin > 50 IU/L
- •Any tumor containing 1 of these components:
- •Yolk sac tumor
- •Choriocarcinoma
- •Embryonal tumor
- •Normal tumor markers allowed
- •Diagnosis confirmed by histology or elevated serum markers
- •Metastatic or nonmetastatic disease
- •Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease
- •Study treatment must begin ≤ 4 weeks after diagnosis
- •No pure immature or mature teratomas
- •The following additional patients are eligible:
- •Patients who are > 18 years of age provided no other appropriate protocol exists
- •Patients who were diagnosed > 4 weeks ago
- •Patients who are in relapse
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •No prior treatment except surgery
- •No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration
- •No concurrent growth factors
- •No other concurrent chemotherapy or radiotherapy
排除标准
- 未提供
结局指标
主要结局
Survival
Event-free survival
次要结局
未报告次要终点
研究者
研究点 (41)
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