Phase 3 N=562 Randomized Treatment

Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme

Brain and Central Nervous System Tumors

Bottom Line

View on ClinicalTrials.gov: NCT00482677 ↗

Enrolled (actual)

562

Serious AEs

54.1%

Results posted

Jan 2018

Primary outcome: Primary: Overall Survival — 9.33; 7.62 Months

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: temozolomide (Drug); DNA methylation analysis (Genetic); quality-of-life assessment (Procedure); Radiation (Radiation)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Canadian Cancer Trials Group
Primary completion: Mar 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00482677). 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.