Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
NCT ID: NCT00004259
Last Updated: 2019-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
230 participants
INTERVENTIONAL
2000-06-30
2018-05-14
Brief Summary
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PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas.
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Detailed Description
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* Compare the overall survival and time to tumor progression in patients with anaplastic astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs carmustine or lomustine vs temozolomide and carmustine (arm discontinued as of 8/15/02).
* Compare the relative toxic effects of these regimens in these patients.
* Correlate molecular analyses with overall survival and time to tumor progression in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior surgery (biopsy only vs resection).
Phase I
* Pilot Arms I and II: Prior to initiating the randomization to 1 of 3 treatment arms in phase III, Patients are accrued to Arm III regimen to determine tolerability.
Phase III
* Patients are randomized to 1 of 2 treatment arms (3rd arm was dropped).
* Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive oral temozolomide on days 1-5 of the first week of radiotherapy. Chemotherapy repeats every 4 weeks for a total of 12 courses.
* Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV or lomustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a second course on days 56-58. Chemotherapy repeats every 8 weeks for a total of 6 courses.
* Arm III (dropped, did not open): Patients undergo radiotherapy as in arm I. Patients receive carmustine IV or lomustine IV over 3 hours on day 5 and oral temozolomide (2 hours after completion of carmustine or lomustine infusion) on days 1-5 of the first week of radiotherapy. Combination chemotherapy repeats every 8 weeks for 6 courses.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Phase I: 30 patients; Phase III: 454 patients (227 per treatment arm) within 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiation therapy + temozolomide (TMZ)
Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
TMZ 200mg/m2
200 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat every 28 days for a total of 12 cycles.
radiation therapy
1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
RT + BCNU/CCNU
Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
BCNU 80mg/m2
BCNU 80 mg/m2 will be administered as an intravenous infusion on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58, then every eight weeks for four more cycles for a total of 6 cycles (maximum BCNU dose 1440 mg/m2).
radiation therapy
1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
CCNU
CCNU at 130 mg/m2 orally every 8 weeks for a total of 6 cycles. Administered on day 1 of the first week of radiotherapy and on day 56, then administered every 8 weeks for four more cycles for a total of 6 cycles.
Pilot Arm #1: RT+TMZ+BCNU
Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
radiation therapy
1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
BCNU 200mg/m2
BCNU 200 mg/m2 will be administered as an intravenous infusion on day 1 of radiotherapy and will be repeated every six weeks for a total of 6 cycles (maximum BCNU dose 1200 mg/m2).
TMZ 150mg/m2 six 6-week cycles
150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 6-week cycles
Pilot Arm #2: RT+TMZ+BCNU
Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
radiation therapy
1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
BCNU 150mg/m2
BCNU 150 mg/m2 will be administered as an intravenous infusion on day 5 of radiotherapy, and it will be repeated every eight weeks for a total of six cycles (maximum total BCNU dose 900 mg/m2).
TMZ 150mg/m2 six 8-week cycles
150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 8-week cycles
Interventions
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BCNU 80mg/m2
BCNU 80 mg/m2 will be administered as an intravenous infusion on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58, then every eight weeks for four more cycles for a total of 6 cycles (maximum BCNU dose 1440 mg/m2).
TMZ 200mg/m2
200 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat every 28 days for a total of 12 cycles.
radiation therapy
1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.
CCNU
CCNU at 130 mg/m2 orally every 8 weeks for a total of 6 cycles. Administered on day 1 of the first week of radiotherapy and on day 56, then administered every 8 weeks for four more cycles for a total of 6 cycles.
BCNU 150mg/m2
BCNU 150 mg/m2 will be administered as an intravenous infusion on day 5 of radiotherapy, and it will be repeated every eight weeks for a total of six cycles (maximum total BCNU dose 900 mg/m2).
BCNU 200mg/m2
BCNU 200 mg/m2 will be administered as an intravenous infusion on day 1 of radiotherapy and will be repeated every six weeks for a total of 6 cycles (maximum BCNU dose 1200 mg/m2).
TMZ 150mg/m2 six 6-week cycles
150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 6-week cycles
TMZ 150mg/m2 six 8-week cycles
150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 8-week cycles
Eligibility Criteria
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Inclusion Criteria
* No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges
* Pathologic evidence of local meningeal infiltration by underlying tumor allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 1 year
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin less than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) less than 2 times ULN
* Alkaline phosphatase less than 2 times ULN
Renal:
* Blood urea nitrogen no greater than 25 mg/dL
* Creatinine less than 1.5 times normal
Pulmonary:
* No pre-existing lung disease that, in the investigator's opinion, would preclude administration of carmustine or lomustine or completion of therapy
Other:
* No other major medical illness or psychiatric impairment that would preclude study compliance
* No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No known hypersensitivity to 1 of the components of carmustine, lomustine, temozolomide, dacarbazine, or any other nitrosourea
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to brain or head and neck
Surgery:
* Not specified
Other:
* No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence is detected
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
North Central Cancer Treatment Group
NETWORK
Eastern Cooperative Oncology Group
NETWORK
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Susan M. Chang, MD
Role: STUDY_CHAIR
University of California, San Francisco
Kurt A. Jaeckle, MD
Role: STUDY_CHAIR
Mayo Clinic
Peter Bushunow, MD
Role: STUDY_CHAIR
Lipson Cancer and Blood Center at Rochester General Hospital
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States
North Bay Cancer Center
Fairfield, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Florida Oncology Associates at Southside Cancer Center
Jacksonville, Florida, United States
Baptist Medical Center South
Jacksonville, Florida, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States
Florida Oncology Associates
Orange Park, Florida, United States
Florida Cancer Center - Palatka
Palatka, Florida, United States
Flagler Cancer Center
Saint Augustine, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
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
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
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Valley Cancer Center
Spring Valley, Illinois, United States
McFarland Clinic, PC
Ames, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
St. John's Regional Health Center
Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Theda Care Cancer Institute
Appleton, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Countries
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References
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Chang SM, Seiferheld W, Curran W, Share R, Atkins J, Choucair A, Kresl J, Thoron L, Cairncross G, Gilbert M, Bahary JP, Dolinskas C, Louis DN, Bushunow P, Buckner J, Barger G, Mehta M. Phase I study pilot arms of radiotherapy and carmustine with temozolomide for anaplastic astrocytoma (Radiation Therapy Oncology Group 9813): implications for studies testing initial treatment of brain tumors. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1122-6. doi: 10.1016/j.ijrobp.2004.01.002.
Other Identifiers
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CDR0000067512
Identifier Type: -
Identifier Source: secondary_id
ECOG-R9813
Identifier Type: -
Identifier Source: secondary_id
NCCTG-RTOG-9813
Identifier Type: -
Identifier Source: secondary_id
RTOG-9813
Identifier Type: -
Identifier Source: org_study_id
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