Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Recruitment status was Active, not recruiting
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.
Brain and Central Nervous System Tumors
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study|
- Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20 [ Time Frame: every 3 months until progression, and then every 6 months until death ] [ Designated as safety issue: No ]
- Mini-Mental State Examination [ Time Frame: every 3 months until progression, and then every 6 months until death ] [ Designated as safety issue: No ]
- Adverse events as measured by CTCAE v3.0 [ Time Frame: As indicated in the protocol ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Radiation: radiation therapy
50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
- 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 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.
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|Study Chair:||Brigitta Baumert, MD, PhD||Maastricht University Medical Center|
|Study Chair:||Roger Stupp, MD||Centre Hospitalier Universitaire Vaudois|