Study on Radiation Therapy With or Without Temozolomide for Treating Low-Grade Glioma
Sponsor: Eastern Cooperative Oncology Group
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
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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:
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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.
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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:
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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)
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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
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Paraffin-embedded tumor specimen available for submission for confirmation of pathological review and determination of 1p and 19q deletion status
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Patients must currently meet ≥ 1 of the following criteria*:
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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
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Tumor progression by serial MRIs, defined as any of the following:
- New or progressive enhancement
- New or progressive T2 or FLAIR signal abnormality
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Age ≥ 40 years
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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.
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Patients who have undergone gross total resection and have no detectable residual disease are eligible
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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:
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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
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No prior radiotherapy to the head unless the radiotherapy ports entirely excluded the brain
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At least 2 weeks since any prior brain surgery (e.g., stereotatic biopsy, open biopsy, or resection)
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At least 6 weeks since prior MRI and chest x-ray
- If resection is performed, an MRI after surgery is required
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UAB Comprehensive Cancer Center | 35294 | Birmingham | Alabama |
| Arizona Oncology Services Foundation | 85013 | Phoenix | Arizona |
| Rebecca and John Moores UCSD Cancer Center | 92093-0658 | La Jolla | California |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | 92868 | Orange | California |
| Aurora Presbyterian Hospital | 80012 | Aurora | Colorado |
| St. Anthony Central Hospital | 80204 | Denver | Colorado |
| Porter Adventist Hospital | 80210 | Denver | Colorado |
| Presbyterian - St. Luke's Medical Center | 80218 | Denver | Colorado |
| St. Joseph Hospital | 80218 | Denver | Colorado |
| CCOP - Colorado Cancer Research Program | 80222 | Denver | Colorado |
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