NCT00274911Unknown2 期
Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours
Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2004年2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
- 30
- 试验地点
- 41
- 主要终点
- Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment
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, cisplatin, and vincristine, 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 followed by combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving radiation therapy followed by combination chemotherapy works in treating young patients with supratentorial primitive neuroectodermal tumors.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors.
Secondary
- Determine overall and relapse-free survival of patients treated with HART followed by adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine.
- Determine the toxicity of this regimen in these patients.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven nonpineal supratentorial primitive neuroectodermal tumors
- •No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas
- •Localized or metastatic disease
- •Metastatic disease is defined as unequivocal evidence of supratentorial metastases and/or spinal metastases on pre-operative or postoperative MRI scan OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage M1) performed between 15 days and 21 days after surgery
- •Has undergone surgical resection within the past 4-6 weeks
- •PATIENT CHARACTERISTICS:
- •Able to cooperate with twice daily fractions of radiotherapy
- •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 performance status 30-100% (for patients 1 to 16 years of age) OR
- •Karnofsky performance status 30-100% (for patients over 16 years of age)
- •Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal impairment)
- •No presence of active uncontrolled infection
- •No previous malignant disease
- •Not pregnant or nursing
- •No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
- •PRIOR CONCURRENT THERAPY:
- •No previous chemotherapy or radiotherapy
- •The patient should not be receiving steroids, if possible, at the start of radiotherapy or should be on a stable or reducing dose of steroids during the week before starting radiotherapy
排除标准
- 未提供
结局指标
主要结局
Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment
次要结局
- Overall and relapse free survival at follow up every 2 months for 1 year, every 3 months for 2 years, and then every 6 months for 2 years
研究者
研究点 (41)
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