NCT00276666Unknown2 期
Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma
Children's Cancer and Leukaemia Group43 个研究点 分布在 2 个国家目标入组 29 人开始时间: 2001年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 29
- 试验地点
- 43
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, vincristine, 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 radiation therapy together with combination chemotherapy after surgery may kill any tumor cells that remain.
PURPOSE: This phase II trial is studying giving radiation therapy together with combination chemotherapy to see how well it works in treating young patients with metastatic medulloblastoma who have undergone surgery.
详细描述
OBJECTIVES:
- Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in young patients with metastatic medulloblastoma.
- Determine the toxicity of chemotherapy (vincristine during radiotherapy and 8 courses of lomustine, cisplatin, and vincristine after radiotherapy) in association with HART in these patients.
OUTLINE: This is a multicenter study.
- Radiotherapy and vincristine: Beginning 4-6 weeks after surgery, patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. Patients also receive vincristine IV once weekly for 8 weeks beginning in week 1*. Approximately 6-8 weeks after completion of radiotherapy, patients proceed to maintenance chemotherapy.
NOTE: *The first 7 patients undergo radiotherapy without receiving vincristine
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven medulloblastoma
- •The following variants of medulloblastoma are also eligible:
- •Nodular/desmoplastic medulloblastoma
- •Medullomyoblastoma
- •Melanotic medulloblastoma
- •Metastatic disease, meeting at least 1 of the following criteria:
- •Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3)
- •Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery
- •Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin)
- •Underwent surgery to remove the tumor no more than 6 weeks ago
- •PATIENT CHARACTERISTICS:
- •Hemoglobin ≥ 10 g/dL
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Neurologically stable (or improving) during the week before starting radiotherapy
- •Lansky (1-16 years) or Karnofsky (>16 years) performance status 30-100%
- •No active infection
- •No prior malignant disease
- •Not pregnant or nursing
- •No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
- •Not require anesthesia
- •No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol
- •PRIOR CONCURRENT THERAPY:
- •No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy
- •No prior chemotherapy or radiotherapy
- •Dexamethasone should not be used as an anti-emetic unless other therapies fail
排除标准
- 未提供
结局指标
主要结局
Toxicity
次要结局
未报告次要终点
研究者
研究点 (43)
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