Phase 2
N=136
Temozolomide and Radiation Therapy in Treating Patients With Gliomas
Brain and Central Nervous System Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00114140 ↗Enrolled (actual)
136
Serious AEs
28.7%
Results posted
Nov 2017
Primary outcome: Primary: Overall Survival Rate at 3 Years — 73.1 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Temozolomide (Drug); Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Rate at 3 Years |
73.1 | <0.001 sig |
| PRIMARY Progression-free Survival |
4.5 | — |
| PRIMARY Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status |
NA; 3.0; NA; 2.0 | 0.0006 sig |
| PRIMARY Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) |
23; 22; 23; 24.5; 24.0; 24.3 | — |
| PRIMARY Neurocognitive Function |
11; 8; 26; 22; 13; 15 | — |
Summary
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed* supratentorial glioma of 1 of the following histologies:
- Astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic)
- Oligodendroglioma
- Oligoastrocytoma Note: *Histologic atypia allowed provided no other histologic features (i.e., frequent mitoses, endothelial proliferation, and/or acute necrosis) that would result in a designation of anaplastic astrocytoma, anaplastic mixed oligodendroglioma or oligoastrocytoma, or glioblastoma multiforme are present
- Unifocal or multifocal disease
- World Health Organization (WHO) grade II disease
- Neurofibromatosis allowed
- Surgical biopsy or resection for tumor tissue sampling required within the past 12 weeks
- Tissue block or core biopsy available for O6-methylguanine-DNA methyltransferase analysis and tissue banking
- Patients who have only had a stereotactic biopsy are not eligible
- Must have ≥ 3 of the following risk factors:
- Age 40 and over
- Largest preoperative tumor diameter ≥ 6 cm
- Tumor crosses the midline
- Astrocytoma-dominant tumor subtype
- Preoperative Neurological Function Status > 1
- No other low-grade glioma histologies, including any of the following:
- Pilocytic astrocytoma
- Subependymal giant cell astrocytoma of tuberous sclerosis
- Subependymoma
- Pleomorphic xanthoastrocytoma
- Presence of a neuronal element, such as ganglioglioma
- Dysneuroembryoplastic epithelial tumor
- No high-grade glioma, including any of the following:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- No tumors in any non-supratentorial location, including any of the following:
- Optic chiasm
- Optic nerve(s)
- Pons
- Medulla
- Cerebellum
- Spinal cord
- No evidence of disease progression to spinal meninges or noncontiguous cranial meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal fluid (CSF) cytology
- MRI of the spine or CSF cytology are not required for patients without symptoms of spinal/cranial meningeal disease progression
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Total bilirubin ≤ 1.5 mg/dL
- Serum glutamate oxaloacetate transaminase (SGOT) or Serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
Renal
- Serum creatinine ≤ 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy or biologic therapy
Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the head and neck unless head and neck radiotherapy clearly excluded the brain (e.g., localized radiotherapy to the vocal cords)
- No prior radiotherapy to the brain
- No concurrent intensity modulated radiotherapy
- No concurrent stereotactic boost radiotherapy
Surgery
- See Disease Characteristics
Other
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00114140). 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.