Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Event-free survival rate
研究概览
简要总结
This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. 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 surgery and radiation therapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the proposed treatment for children >= 8.0 months and < 3 years of age at registration with non-metastatic (M0) medulloblastoma is more effective than the combined treatments given to children of the same age and extent of disease on POG 9233, as measured by event-free survival (EFS) rates.
SECONDARY OBJECTIVES:
I. To assess the feasibility and safety of the planned use of second look surgery and focal conformal radiation therapy following chemotherapy. II. To determine the acute and chronic toxicities associated with the above treatment regimens.
III. To describe the neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation. IV. To determine the feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations. V. To determine the incidence of atypical teratoid/rhabdoid tumor (AT/RT) in children enrolled on this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor
- •Prior definitive tumor resection within 6 weeks of study
- •No evidence of metastases
- •Hemoglobin at least 10 g/dL
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •AST less than 2.5 times normal
- •Bilirubin less than 1.5 mg/dL
- •Creatinine less than 1.2 mg/dL
- •Creatinine clearance greater than 70 mL/min
- •No prior chemotherapy
- •No prior radiotherapy
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Chemotherapy, surgery, radiation therapy
Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
干预措施: cisplatin (Drug)
Chemotherapy, surgery, radiation therapy
Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
干预措施: therapeutic conventional surgery (Procedure)
Chemotherapy, surgery, radiation therapy
Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
干预措施: cyclophosphamide (Drug)
Chemotherapy, surgery, radiation therapy
Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
干预措施: vincristine sulfate (Drug)
Chemotherapy, surgery, radiation therapy
Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
干预措施: etoposide (Drug)
Chemotherapy, surgery, radiation therapy
Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
结局指标
主要结局
Event-free survival rate
时间窗: 1 year
次要结局
- Acute and chronic toxicities associated with the treatment regimens(Up to 9 years)
- Neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation(Up to 9 years)
- Feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations(Up to 9 years)
- Incidence of atypical teratoid and/or rhabdoid tumor(Up to 9 years)