Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery. Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.

Official Title
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SIOP Study of Combined Modality Treatment in Childhood Ependymoma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: cyclophosphamide
* Drug: etoposide
* Drug: vincristine sulfate
* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven nonmetastatic intracranial ependymoma Cellular Papillary Clear cell Mixed cell Anaplastic No myxopapillary ependymoma, subependymoma, or ependymoblastoma PATIENT CHARACTERISTICS: Age: 3 to 20 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No hematologic disease that would preclude study participation Hepatic: Not specified Renal: No renal disease that would preclude study participation Other: 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 Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Drug: etoposide|nan|
|Drug: vincristine sulfate|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: conventional surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  |  | 
| Overall survival |  |  | 
| Surgical operability |  |  | 
| Response rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma