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临床试验/NCT00281905
NCT00281905Unknown2 期

Management of Children Aged Less Than 3 Years With Brain Tumors

Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 50 人开始时间: 1992年6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
50
试验地点
41
主要终点
Local recurrence or occurrence of CNS metastases

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors.

详细描述

OBJECTIVES:

  • Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.
  • Determine the event-free survival and overall survival in children treated with this regimen.
  • Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.
  • Determine the quality of life in children treated with this regimen.
  • Determine the tolerability and long-term toxicity of this regimen in these children.
  • Determine the proportion of children who require radiotherapy after treatment with this regimen.
  • Determine the prognosis of children who receive both chemotherapy and radiotherapy.
  • Determine the nature and behavior of brain tumors in very young children.

OUTLINE: This is a multicenter study.

  • Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.
  • Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.
  • Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.

Quality of life is assessed 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 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • DISEASE CHARACTERISTICS:
  • Diagnosis of 1 of the following:
  • Brain stem tumor (histological confirmation not required)
  • Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:
  • Anaplastic (malignant) astrocytoma
  • Glioblastoma
  • Anaplastic (malignant) oligodendroglioma
  • Ependymoma
  • Anaplastic (malignant) ependymoma
  • Anaplastic (malignant) oligoastrocytoma
  • Choroid plexus carcinoma
  • Astroblastoma
  • Polar spongioblastoma
  • Gliomatosis cerebri
  • Anaplastic (malignant) ganglioglioma
  • Pineoblastoma
  • Mixed pineocytoma or pineoblastoma
  • Medulloepithelioma
  • Neuroblastoma
  • Ependymoblastoma
  • Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs
  • Has undergone surgery or biopsy of the tumor within the past 2-4 weeks
  • PATIENT CHARACTERISTICS:
  • No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy or radiotherapy
  • Prior steroids allowed
  • No concurrent steroids as anti-emetics
  • Concurrent steroids allowed for control of tumor-related symptoms

排除标准

  • 未提供

结局指标

主要结局

Local recurrence or occurrence of CNS metastases

Response rate

Event-free survival

Quality of survival

Long-term toxicity

Tolerance

Proportion of patients requiring radiotherapy

Prognosis of children who receive both chemotherapy and radiotherapy

Nature and behavior of brain tumors

次要结局

未报告次要终点

研究者

发起方
Children's Cancer and Leukaemia Group
申办方类型
Other

研究点 (41)

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