Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
NCT ID: NCT00033280
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2002-07-31
2018-05-14
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
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Detailed Description
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* Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
* Determine the toxicity of this regimen in these patients.
* Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).
Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.
Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.
Patients with CR after completion of neoadjuvant temozolomide undergo observation.
Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
temozolomide
neoadjuvant therapy
radiation therapy
Interventions
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temozolomide
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
* No spinal cord tumors
* No evidence of spinal drop metastasis or spread to noncontiguous meninges
PATIENT CHARACTERISTICS:
Age:
* 18 to 65
Performance status:
* Zubrod 0-1
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin no greater than 2 times normal
* Aspartate aminotransferase (AST) no greater than 3 times normal
* Alkaline phosphatase no greater than 2 times normal
Renal:
* Creatinine no greater than 1.5 times normal
Other:
* No active infection
* No other medical problems that would preclude study participation
* No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy for this malignancy
* No prior temozolomide
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to the brain, head, or neck
Surgery:
* At least 14 days since prior surgery requiring general anesthesia
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Michael A. Vogelbaum, MD, PhD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Cancer Center
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Anderson Area Cancer Center
Anderson, South Carolina, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Countries
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References
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Vogelbaum MA, Berkey B, Peereboom D, Macdonald D, Giannini C, Suh JH, Jenkins R, Herman J, Brown P, Blumenthal DT, Biggs C, Schultz C, Mehta M. Phase II trial of preirradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: RTOG BR0131. Neuro Oncol. 2009 Apr;11(2):167-75. doi: 10.1215/15228517-2008-073. Epub 2008 Sep 8.
Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas: relationship between 1p/19q status and progression-free survival. [Abstract] J Clin Oncol 24 (Suppl 18): A-1517, 2006.
Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas. [Abstract] J Clin Oncol 23 (Suppl 16): A-1520, 119s, 2005.
Other Identifiers
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CDR0000069270
Identifier Type: -
Identifier Source: secondary_id
RTOG-BR-0131
Identifier Type: -
Identifier Source: org_study_id
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