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ACTIVE NOT RECRUITING

NCT00978458

PHASE3

Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma

Sponsor: Eastern Cooperative Oncology Group

View on ClinicalTrials.gov

Summary

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.

Official title: Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

540

Start Date

2009-11-17

Completion Date

2026-12-31

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Brain and Central Nervous System Tumors Neurotoxicity

Interventions

DRUG

temozolomide

Given orally

RADIATION

3-dimensional conformal radiation therapy

Given once daily 5 days a week for 5½ weeks

RADIATION

intensity-modulated radiation therapy

Given once daily 5 days a week for 5½ weeks

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 required

Locations (168)

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Arizona Oncology Services Foundation

Phoenix, Arizona, United States

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

Aurora Presbyterian Hospital

Aurora, Colorado, United States

St. Anthony Central Hospital