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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Neurotoxicity

Eligibility:

All Genders

18-120 years

Phase:

PHASE3

Brief 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...

Detailed Description

OBJECTIVES: Primary * To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grad...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 17 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2026

    Estimated Enrollment :

    540 Patients enrolled

    Trial Details

    Trial ID

    NCT00978458

    Start Date

    November 17 2009

    End Date

    December 31 2026

    Last Update

    September 8 2025

    Active Locations (168)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 42 (168 locations)

    1

    UAB Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294

    2

    Arizona Oncology Services Foundation

    Phoenix, Arizona, United States, 85013

    3

    Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, United States, 92093-0658

    4

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

    Orange, California, United States, 92868