Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
European Organisation for Research and Treatment of Cancer - EORTC
With
OBJECTIVES: Primary * Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide. Secondary * 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 unacceptable toxicity. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
