Phase 3
Completed N=562
Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
Source: ClinicalTrials.gov NCT00482677 ↗Enrolled (actual)
562
Serious AEs
54.1%
Results posted
Jan 2018
Primary outcomePrimary: Overall Survival — 9.33; 7.62 Months
◆ Published Evidence
Highly cited
1,183citations · ~131 / year
Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma.
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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.
Linked Publications (3)
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Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma.
-
Temozolomide and seizure outcomes in a randomized clinical trial of elderly glioblastoma patients.
-
Elderly patients with glioblastoma: the treatment challenge.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
9.33; 7.62 | — |
| SECONDARY Progression-free Survival |
5.29; 3.94 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter |
13.47; 7.69 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histopathologically confirmed glioblastoma multiforme
- Grade IV disease by WHO classification
- Newly diagnosed disease
- Initial diagnostic surgery or biopsy performed within the past 4 weeks
- Not a candidate for standard radiotherapy (60Gy/30 fractions over 6 weeks) in combination with temozolomide
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- ALT and AST < 2.5 times ULN
- No known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
- No history of other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
- No serious active infection (e.g., wound infection requiring parenteral antibiotics) or other serious underlying medical conditions that would preclude study treatment
- No other condition (e.g., psychological or geographical) that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy
- No prior or concurrent investigational therapy
- No concurrent surgical procedures for tumor debulking
- No concurrent stereotactic boost radiotherapy
- No other concurrent chemotherapy, immunotherapy, or biological therapy
- No concurrent epoetin alfa
- Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for at least 14 days
Data sourced from ClinicalTrials.gov (NCT00482677) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.