Trial Information

A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma

OBJECTIVES:

- Compare the event-free survival rate in pediatric patients with standard-risk
medulloblastoma treated with conventional vs hyperfractionated radiotherapy and
vincristine followed by maintenance with cisplatin, lomustine, and vincristine.

- Compare the overall survival of patients treated with these regimens.

- Compare the pattern of relapse, especially local relapse (tumor bed or posterior fossa
outside tumor bed), in patients treated with these regimens.

- Determine the toxicity of surgery and whether there are identifiable factors that
correlate with toxicity in these patients.

- Determine the impact of any surgical complications on commencement of adjuvant therapy
and event-free survival of these patients.

- Compare late sequelae, in terms of health status, endocrine deficiencies, and hearing
loss, in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
country. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Within 28-40 days after surgical resection, patients undergo conventional
fractionated radiotherapy once daily, 5 days a week, for 6-7 weeks. Patients also
receive vincristine IV once weekly for 8 weeks.

- Arm II: Beginning as in arm I, patients undergo hyperfractionated radiotherapy twice
daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine as in arm I.

- Maintenance chemotherapy:Six weeks after completion of radiotherapy, all patients
receive cisplatin IV over 6 hours and oral lomustine on day 1 and vincristine IV on
days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses.

Patients are followed at least every 6 months for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 316 patients (158 per treatment arm) will be accrued for this
study within 4 years.