Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Run by Eastern Cooperative Oncology Group · NCT00978458 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2026-12-31.
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…
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 540 (actual) |
| Sponsor | Eastern Cooperative Oncology Group Research network |
| Drugs / interventions | temozolomide, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy |
| Locations | 168 sites (United States) |
| Trial ID | NCT00978458 on ClinicalTrials.gov |
What this trial studies
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-grade gliomas. * To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients. Secondary * To determine whether combination therapy with temozolomide and radiotherapy improves or maintains cognition and quality of life compared to radiotherapy alone. * To compare the toxicities (severe or worse \[≥ grade 3\]) of radiotherapy with vs without temozolomide in these patients. * To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS. * To determine the impact of 1p and 19q status on PFS and OS of patients treated with temozolomide. * To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG Pathology Coordinating Office. OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 40 years vs ≥ 40 years), 1p and 19q status (both deleted vs either/both intact vs undeterminable), pre-operative maximum tumor diameter (\< 6 cm vs ≥ 6 cm \[based on T2 or FLAIR MRI\]), Karnofsky performance status (60-70% vs 80-100%), and contrast enhancement on pre-treatment MRI scan (present vs absent). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5…
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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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
Denver, Colorado, United States
Show 44 more locations
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Porter Adventist Hospital
Denver, Colorado, United States -
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States -
St. Joseph Hospital
Denver, Colorado, United States -
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States -
Swedish Medical Center
Englewood, Colorado, United States -
Sky Ridge Medical Center
Lone Tree, Colorado, United States -
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States -
CCOP - Christiana Care Health Services
Newark, Delaware, United States -
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States -
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States -
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States -
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States -
St. Joseph Medical Center
Bloomington, Illinois, United States -
Graham Hospital
Canton, Illinois, United States -
Illinois CancerCare - Canton
Canton, Illinois, United States -
Illinois CancerCare - Carthage
Carthage, Illinois, United States -
Memorial Hospital
Carthage, Illinois, United States -
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States -
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States -
University of Illinois Cancer Center
Chicago, Illinois, United States -
University of Chicago Cancer Research Center
Chicago, Illinois, United States -
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States -
Eureka Community Hospital
Eureka, Illinois, United States -
Illinois CancerCare - Eureka
Eureka, Illinois, United States -
Evanston Hospital
Evanston, Illinois, United States -
Galesburg Clinic, PC
Galesburg, Illinois, United States -
Illinois CancerCare - Havana
Havana, Illinois, United States -
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States -
La Grange Memorial Hospital
La Grange, Illinois, United States -
Illinois CancerCare - Macomb
Macomb, Illinois, United States -
McDonough District Hospital
Macomb, Illinois, United States -
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States -
OSF Holy Family Medical Center
Monmouth, Illinois, United States -
BroMenn Regional Medical Center
Normal, Illinois, United States -
Community Cancer Center
Normal, Illinois, United States -
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States -
Community Hospital of Ottawa
Ottawa, Illinois, United States -
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States -
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States -
Illinois CancerCare - Pekin
Pekin, Illinois, United States -
Proctor Hospital
Peoria, Illinois, United States -
OSF St. Francis Medical Center
Peoria, Illinois, United States -
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States -
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
+118 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: David Schiff, MD — University of Virginia
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.