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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033280 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas |
| Study Start Date: | July 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Arizona | |
| CCOP - Mayo Clinic Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| Foundation for Cancer Research and Education | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Florida | |
| Baptist Hospital of Miami | |
| Miami, Florida, United States, 33256-2110 | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Shands Cancer Center at the University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0385 | |
| University of Miami Sylvester Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| United States, Nebraska | |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New Jersey | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740-6395 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139-0000 | |
| Wayne Memorial Hospital, Inc. | |
| Goldsboro, North Carolina, United States, 27533 | |
| United States, Ohio | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44304 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623-3456 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055-2899 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750-1635 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Mercy Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| United States, South Carolina | |
| Anderson Area Cancer Center | |
| Anderson, South Carolina, United States, 29621-5705 | |
| United States, Utah | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center | |
| Saint George, Utah, United States, 84770 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| University of Utah Health Sciences Center | |
| Salt Lake City, Utah, United States, 84132 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Washington | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Study Chair: | Michael A. Vogelbaum, MD, PhD | The Cleveland Clinic |
More Information
| Study ID Numbers: | CDR0000069270, RTOG-BR-0131, RTOG-DEV-1080 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033280 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult anaplastic oligodendroglioma adult mixed glioma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Oligodendroglioma Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |