A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)
OBJECTIVES:
- 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 (closed as of 8/15/02)
- Prior to initiating the randomization to 1 of 3 treatment arms in phase III, 15
patients are accrued to arm III. If 2 or more of the first 15 patients experience grade
3 or worse pulmonary toxicity OR if 5 or more of the first 15 patients experience grade
4-5 thrombocytopenia/neutropenia, then arm III treatment is discontinued.
Phase III
- Patients are randomized to 1 of 2 treatment arms.
- 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 (discontinued as of 8/15/02): 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: A total of 30 patients will be accrued for phase I of the study and then
a total of 454 patients (227 per treatment arm) will be accrued for phase III of the study
within 4 years. (Phase I closed as of 8/15/02)
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival (OS)
No
Susan M. Chang, MD
Study Chair
University of California, San Francisco
United States: Federal Government
CDR0000067512
NCT00004259
June 2000
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Wesley Medical Center | Wichita, Kansas 67214 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Southwest Medical Center | Liberal, Kansas 67901 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
North Bay Cancer Center | Fairfield, California 94533 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre, Pennsylvania 18840 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton, Florida 33486 |
Florida Oncology Associates at Southside Cancer Center | Jacksonville, Florida 32207 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Oncology Associates | Orange Park, Florida 32073 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
Lipson Cancer and Blood Center at Rochester General Hospital | Rochester, New York 14621 |