Clinical trial · Interventional
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
NCT00978458CI-TRIAL-00094727active not recruitingPhase 3ClinicalTrials.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: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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 radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma. PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.
Conditions
Conditions (2)
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 | — |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
- interventionNames
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: intensity-modulated radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: temozolomide
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: intensity-modulated radiation therapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed\* supratentorial low-grade glioma, including 1 of the following:
* Grade 2 astrocytoma
* Grade 2 oligodendroglioma
* Grade 2 oligoastrocytoma (mixed glioma containing astrocytoma and oligodendroglioma)
* NOTE: \*If the pathology from multiple procedures supports the diagnosis of a brain tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma must be the most recent pathological diagnosis; no pathological diagnosis of grade 3 or 4 glioma at any time
* Paraffin-embedded tumor specimen available for submission for confirmation of pathological review and determination of 1p and 19q deletion status
* Patients must currently meet ≥ 1 of the following criteria\*:
* Uncontrolled symptoms, defined as any of the following:
* Headaches associated with mass effect
* Uncontrolled seizures despite two different antiepileptic drug regimens (i.e., two antiepileptic drugs tested either sequentially or in combination)
* Focal neurological symptoms
* Cognitive symptoms or deficits
* Tumor progression by serial MRIs, defined as any of the following:
* New or progressive enhancement
* New or progressive T2 or FLAIR signal abnormality
* Age ≥ 40 years
* NOTE: \*Patients \< 40 years of age whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs AND who have no evidence of radiographic progression are not eligible.
* Patients who have undergone gross total resection and have no detectable residual disease are eligible
* No pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* WBC ≥ 3,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hematocrit ≥ 30%
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* Creatinine ≤ 2.0 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Able to undergo MRI with and without contrast
* No other malignancy within the past 5 years, except for nonmelanoma skin cancer or cervical carcinoma in situ
* No uncontrolled infection
* No known HIV positivity
* No medical disorder that would increase risks associated with radiotherapy and temozolomide
* No other disorder that would limit life expectancy to \< 5 years
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy, cytotoxic chemotherapy, radiosurgery, or investigational therapy directed at the brain tumor
* Any number of prior surgical procedures for the brain tumor allowed
* No prior radiotherapy to the head unless the radiotherapy ports entirely excluded the brain
* At least 2 weeks since any prior brain surgery (e.g., stereotatic biopsy, open biopsy, or resection)
* At least 6 weeks since prior MRI and chest x-ray
* If resection is performed, an MRI after surgery is requiredReferences
Publications (0)
Data not yet available
No reference posted for this study.