Trial Information

A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV

OBJECTIVES:

- Compare the efficacy of temozolomide vs procarbazine, lomustine, and vincristine, in
terms of overall survival, in patients with recurrent malignant glioma.

- Compare progression-free survival of patients treated with these regimens.

- Compare progression-free survival at 12 weeks in patients treated with two different
schedules of temozolomide.

- Compare the overall survival of patients treated with two different schedules of
temozolomide.

- Compare toxic effects of two different schedules of temozolomide in these patients.

- Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I:Patients are randomized to 1 of 2 treatment schedules:

- Schedule 1: Patients receive oral temozolomide once daily on days 1-5.

- Schedule 2:Patients receive oral temozolomide once daily on days 1-21. Treatment
on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence
of disease progression or unacceptable toxicity.

- Arm II:Patients receive oral lomustine and vincristine IV on day 1 and oral
procarbazine on days 1-21. Treatment repeats every 6 weeks for a maximum of 6 courses
in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at 12 and 24 weeks.

Patients are followed every 12 weeks.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study.