Clinical trial · Interventional
Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme
Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. 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 standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme. PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo standard radiotherapy 5 days a week for 6 weeks.
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
- interventionNames
- Radiation: hypofractionated radiation therapy
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Grade 4 disease (WHO) PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 (PS 3-4 allowed if secondary to a neurological physical handicap) * Life expectancy ≥ 3 months * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * Transaminases ≤ 3 times ULN * Creatinine \< 1.5 times ULN * Able to tolerate the 3 treatment options * No other malignancy within the past 5 years except for curatively treated basal cell or squamous cell carcinoma of the skin * No acute or chronic severe illness that, in the investigator's opinion, contraindicates participation in the study PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or immunotherapy * Concurrent corticosteroids allowed provided patient is receiving the lowest dose necessary for optimal functioning
References
Publications (0)
Data not yet available