Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

PHASE3CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

June 30, 2000

Primary Completion Date

February 1, 2015

Study Completion Date

May 14, 2018

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

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).

DRUG

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

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.

DRUG

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.

DRUG

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).

DRUG

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).

DRUG

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

DRUG

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

Trial Locations (92)

14621

Lipson Cancer and Blood Center at Rochester General Hospital, Rochester

15212

Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh

18840

Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

28801

Mission Hospitals - Memorial Campus, Asheville

31904

John B. Amos Cancer Center, Columbus

32073

Florida Oncology Associates, Orange Park

32086

Flagler Cancer Center, Saint Augustine

32177

Florida Cancer Center - Palatka, Palatka

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

Florida Oncology Associates at Southside Cancer Center, Jacksonville

32250

Integrated Community Oncology Network, Jacksonville Beach

32258

Baptist Medical Center South, Jacksonville

33486

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center, Boca Raton

44106

Case Comprehensive Cancer Center, Cleveland

44460

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem

44691

Cancer Treatment Center, Wooster

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

50010

McFarland Clinic, PC, Ames

53051

Community Memorial Hospital Cancer Care Center, Menomonee Falls

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54401

University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau

54911

Theda Care Cancer Institute, Appleton

55805

CCOP - Duluth, Duluth

57701

Rapid City Regional Hospital, Rapid City

59101

CCOP - Montana Cancer Consortium, Billings

61350

Community Hospital of Ottawa, Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa

61354

Illinois Valley Community Hospital, Peru

61356

Perry Memorial Hospital, Princeton

61362

St. Margaret's Hospital, Spring Valley

Valley Cancer Center, Spring Valley

61401

Galesburg Clinic, Galesburg

Galesburg Cottage Hospital, Galesburg

InterCommunity Cancer Center of Western Illinois, Galesburg

61443

Kewanee Hospital, Kewanee

61455

McDonough District Hospital, Macomb

61520

Graham Hospital, Canton

61530

Eureka Community Hospital, Eureka

61554

Cancer Treatment Center at Pekin Hospital, Pekin

61614

Proctor Hospital, Peoria

61615

CCOP - Illinois Oncology Research Association, Peoria

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61701

St. Joseph Medical Center, Bloomington

61747

Hopedale Medical Complex, Hopedale

61761

BroMenn Regional Medical Center, Normal

Community Cancer Center, Normal

62321

Memorial Hospital, Carthage

62644

Mason District Hospital, Havana

65804

St. John's Regional Health Center, Springfield

66604

Cotton-O'Neil Cancer Center, Topeka

66720

Cancer Center of Kansas, PA - Chanute, Chanute

67042

Cancer Center of Kansas, PA - El Dorado, El Dorado

Cancer Center of Kansas, PA - Salina, Salina

67068

Cancer Center of Kansas, PA - Kingman, Kingman

67114

Cancer Center of Kansas, PA - Newton, Newton

67124

Cancer Center of Kansas, PA - Pratt, Pratt

67152

Cancer Center of Kansas, PA - Wellington, Wellington

67156

Cancer Center of Kansas, PA - Winfield, Winfield

67203

Associates in Womens Health, PA - North Review, Wichita

67208

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita

67214

Cancer Center of Kansas, PA - Wichita, Wichita

CCOP - Wichita, Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita

Wesley Medical Center, Wichita

67357

Cancer Center of Kansas, PA - Parsons, Parsons

67801

Cancer Center of Kansas, PA - Dodge City, Dodge City

67901

Southwest Medical Center, Liberal

68114

Methodist Cancer Center at Methodist Hospital - Omaha, Omaha

74136

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa

84143

Latter Day Saints Hospital, Salt Lake City

85013

Arizona Oncology Services Foundation, Phoenix

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

94533

North Bay Cancer Center, Fairfield

95687

Solano Radiation Oncology Center, Vacaville

95926

Enloe Cancer Center at Enloe Medical Center, Chico

36652-2144

Mobile Infirmary Medical Center, Mobile

32610-0232

University of Florida Shands Cancer Center, Gainesville

33612-9497

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa

61615-7827

OSF St. Francis Medical Center, Peoria

49007-3731

West Michigan Cancer Center, Kalamazoo

59107-7000

Deaconess Billings Clinic - Downtown, Billings

68848-1990

Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

08360

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland

08043

Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees Township

44309-2090

Akron City Hospital, Akron

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19612-6052

Reading Hospital and Medical Center, Reading

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

North Central Cancer Treatment Group

NETWORK

collaborator

Eastern Cooperative Oncology Group

NETWORK

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK