NCT00274911

Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors

Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, cisplatin, and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy followed by combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving radiation therapy followed by combination chemotherapy works in treating young patients with supratentorial primitive neuroectodermal tumors.

Detailed description

OBJECTIVES: Primary * Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors. Secondary * Determine overall and relapse-free survival of patients treated with HART followed by adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. * Radiotherapy: Patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. * Adjuvant combination chemotherapy: Six weeks after the last radiotherapy dose, patients receive oral lomustine once and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 . Treatment repeats every 6 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 5 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	lomustine
DRUG	vincristine sulfate
PROCEDURE	adjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 2004-02-01
• Primary completion: 2010-03-01
• First posted: 2006-01-11
• Last updated: 2013-08-02

Locations

21 sites across 2 countries: Ireland, United Kingdom