NCT00004224

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

SIOP Study of Combined Modality Treatment in Childhood Ependymoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Societe Internationale d'Oncologie Pediatrique · Academic / Other
• Sex: All
• Age: 3 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	vincristine sulfate
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 1999-01-01
• Completion: 2008-03-01
• First posted: 2003-01-27
• Last updated: 2013-08-26

Locations

7 sites across 7 countries: Argentina, Canada, Italy, Netherlands, Spain, Sweden, United Kingdom