Study on Radiation Therapy With or Without Temozolomide for Treating Low-Grade Glioma

Sponsor: Eastern Cooperative Oncology Group

Sponsor score: 0

ClinicalTrials ID:NCT00978458

This clinical trial is exploring whether adding the chemotherapy drug temozolomide to radiation therapy can improve treatment outcomes for patients with low-grade glioma, a type of brain tumor.

Patient Parameters

Program Overview

The study aims to find out if combining radiation therapy with the chemotherapy drug temozolomide is more effective than radiation therapy alone in treating patients with low-grade glioma. Radiation therapy uses high-energy x-rays to target and kill tumor cells, while temozolomide works by stopping tumor cells from growing or dividing. Researchers want to see if this combination can help patients live longer without the cancer getting worse and improve their overall survival.

Description

This study is designed to compare two treatment approaches for patients with low-grade glioma, a type of brain tumor. The main goal is to see if adding the chemotherapy drug temozolomide to radiation therapy can help patients live longer without their cancer getting worse and improve their overall survival.

In this study, patients are randomly assigned to one of two groups:

  • Group 1: Patients receive radiation therapy alone. This involves receiving high-energy x-rays targeted at the tumor once a day, five days a week, for about five and a half weeks.

  • Group 2: Patients receive the same radiation therapy as Group 1, but they also take the chemotherapy drug temozolomide by mouth every day during the radiation treatment. After finishing radiation, they continue taking temozolomide for five days every month for up to a year, as long as the cancer does not progress and side effects are manageable.

The study also looks at whether this combination treatment affects patients' thinking abilities and quality of life compared to radiation therapy alone. Researchers will collect tumor tissue samples and blood for further analysis and to help understand the genetic factors that might influence treatment outcomes.

Patients will be followed up regularly for up to 15 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

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

FACILITYZIPCITYSTATE
UAB Comprehensive Cancer Center35294BirminghamAlabama
Arizona Oncology Services Foundation85013PhoenixArizona
Rebecca and John Moores UCSD Cancer Center92093-0658La JollaCalifornia
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center92868OrangeCalifornia
Aurora Presbyterian Hospital80012AuroraColorado
St. Anthony Central Hospital80204DenverColorado
Porter Adventist Hospital80210DenverColorado
Presbyterian - St. Luke's Medical Center80218DenverColorado
St. Joseph Hospital80218DenverColorado
CCOP - Colorado Cancer Research Program80222DenverColorado

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