Clinical trial · Interventional
Temozolomide and Radiation Therapy in Treating Patients With Gliomas
A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas
NCT00114140CI-TRIAL-00078608completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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: 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide + Radiation Therapy (RT)
- description
- Daily temozolomide plus concurrent radiotherapy followed by temozolomide
- interventionNames
- Drug: Temozolomide
- Radiation: Radiation therapy
Primary outcomes (5)
- measure
- Overall Survival Rate at 3 Years
- timeFrame
- Registration to 3 years
- description
- Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years.
- measure
- Progression-free Survival
- timeFrame
- From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBell EH, Zhang P, Fisher BJ, Macdonald DR, McElroy JP, Lesser GJ, Fleming J, Chakraborty AR, Liu Z, Becker AP, Fabian D, Aldape KD, Ashby LS, Werner-Wasik M, Walker EM, Bahary JP, Kwok Y, Yu HM, Laack NN, Schultz CJ, Gray HJ, Robins HI, Mehta MP, Chakravarti A. Association of MGMT Promoter Methylation Status With Survival Outcomes in Patients With High-Risk Glioma Treated With Radiotherapy and Temozolomide: An Analysis From the NRG Oncology/RTOG 0424 Trial. JAMA Oncol. 2018 Oct 1;4(10):1405-1409. doi: 10.1001/jamaoncol.2018.1977. PMID 29955793