Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study
- Compare the progression-free survival of patients with low-grade gliomas treated with
radiotherapy vs temozolomide.
- Compare the overall survival of patients treated with these regimens.
- Determine whether the incidence of late toxicity can be decreased in patients who are
randomized to receive temozolomide.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to participating center, chromosome 1p status (deleted vs normal vs
undeterminable), contrast enhancement on MRI (yes vs no), age (< 40 years vs ≥ 40 years),
and WHO performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily, 5 days a week, for a total of 28
fractions (i.e., 5½ weeks).
- Arm II: Patients receive oral temozolomide once daily on days 1-21. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or
Quality of life is assessed at baseline and then every 3 months until disease progression.
After completion of study treatment, patients are followed every 6 months for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A minimum of 699 patients (a total of 466 randomized [233 per treatment
arm]) will be accrued for this study within 5 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Brigitta Baumert, MD, PhD
Maastricht University Medical Center
Canada: Health Canada