Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours
- Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in
pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors.
- 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
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment
Frank Saran, MD
Royal Marsden NHS Foundation Trust
United States: Federal Government