Radiation Therapy or Temozolomide in Treating Patients With Gliomas
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00182819
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 709
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description radiotherapy radiation therapy Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques Temozolomide temozolomide Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
- Primary Outcome Measures
Name Time Method Progression-free survival 5 years
- Secondary Outcome Measures
Name Time Method Overall survival 5 years Adverse events as measured by CTCAE v3.0 As indicated in the protocol Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20 every 3 months until progression, and then every 6 months until death Mini-Mental State Examination every 3 months until progression, and then every 6 months until death
Trial Locations
- Locations (89)
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre
🇦🇺Heidelberg West, Victoria, Australia
Alfred Hospital
🇦🇺Prahran, Victoria, Australia
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