SIOP Study of Combined Modality Treatment in Childhood Ependymoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 14
- 主要终点
- Overall survival
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.
详细描述
OBJECTIVES:
- Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.
- Determine the response rate in these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.
Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.
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 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven nonmetastatic intracranial ependymoma
- •Papillary
- •Clear cell
- •Mixed cell
- •Anaplastic
- •No myxopapillary ependymoma, subependymoma, or ependymoblastoma
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •No hematologic disease that would preclude study participation
- •Not specified
- •No renal disease that would preclude study participation
- •No concurrent unrelated disease that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Prior steroids allowed
- •Radiotherapy:
- •No prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Overall survival
Surgical operability
Response rate
Event-free survival
次要结局
未报告次要终点