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Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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.
- - 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.
- - 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.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00978458 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eastern Cooperative Oncology Group |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
David Schiff, MD |
| Principal Investigator Affiliation | University of Virginia |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Active, not recruiting |
| Countries | United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain and Central Nervous System Tumors, Neurotoxicity |
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.
- - 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.#46; 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.
- - Arm I: Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
- - Arm II: Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks.
Arms
Active Comparator: Arm I
Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
Experimental: Arm II
Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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UAB Comprehensive Cancer Center
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Eastern Connecticut Hematology and Oncology Associates
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Mayo Clinic - Jacksonville
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Florida Hospital Cancer Institute at Florida Hospital Orlando
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Winship Cancer Institute of Emory University
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Illinois CancerCare - Bloomington
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Illinois CancerCare - Canton
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Illinois CancerCare - Carthage
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
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University of Illinois Cancer Center
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University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
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Decatur Memorial Hospital Cancer Care Institute
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Eureka Community Hospital
Eureka, Illinois, 61530
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Illinois CancerCare - Eureka
Eureka, Illinois, 61530
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Evanston Hospital
Evanston, Illinois, 60201-1781
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Galesburg Clinic, PC
Galesburg, Illinois, 61401
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Illinois CancerCare - Havana
Havana, Illinois, 62644
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Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443
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La Grange Memorial Hospital
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Illinois CancerCare - Macomb
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McDonough District Hospital
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Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462
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OSF Holy Family Medical Center
Monmouth, Illinois, 61462
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BroMenn Regional Medical Center
Normal, Illinois, 61761
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Community Cancer Center
Normal, Illinois, 61761
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Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761
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Community Hospital of Ottawa
Ottawa, Illinois, 61350
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Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350
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Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554
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Illinois CancerCare - Pekin
Pekin, Illinois, 61603
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Proctor Hospital
Peoria, Illinois, 61614
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OSF St. Francis Medical Center
Peoria, Illinois, 61615-7827
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CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615
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Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615
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Methodist Medical Center of Illinois
Peoria, Illinois, 61636
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Illinois CancerCare - Peru
Peru, Illinois, 61354
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Illinois Valley Community Hospital
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Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362
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Valley Cancer Center
Spring Valley, Illinois, 61362
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Parkview Regional Cancer Center at Parkview Health
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Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, 46219
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Community Regional Cancer Care at Community Hospital North
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Michiana Hematology-Oncology, PC - South Bend
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CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
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Flint, Michigan, 48503
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Kalamazoo, Michigan, 49007-3731
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Rochester, Minnesota, 55905
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Saint Louis Park, Minnesota, 55416
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Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101
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Utah Valley Regional Medical Center - Provo
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Richmond, Virginia, 23298-0037
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La Crosse, Wisconsin, 54601
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Milwaukee, Wisconsin, 53226
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Weston, Wisconsin, 54476
