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

Last updated: August 28, 2019
Sponsor: Radiation Therapy Oncology Group
Overall Status: Completed

Phase

3

Condition

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT00004259
RTOG-9813
ECOG-R9813
NCCTG-RTOG-9813
CDR0000067512
  • Ages 18-120
  • All Genders

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following:

  • Anaplastic astrocytoma

  • Mixed oligodendroglial/astrocytic tumors

  • Oligodendroglial component must be no greater than 25%

  • No vascular proliferation and necrosis

  • Increased cellularity, pleomorphism, and nuclear atypia allowed

  • No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)

  • Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible

  • Study therapy must begin within 6 weeks of diagnosis

  • 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

Study Design

Total Participants: 230
Study Start date:
June 01, 2000
Estimated Completion Date:
May 14, 2018

Study Description

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

  • 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.

Connect with a study center

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36652-2144
    United States

    Site Not Available

  • Arizona Oncology Services Foundation

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California 95926
    United States

    Site Not Available

  • North Bay Cancer Center

    Fairfield, California 94533
    United States

    Site Not Available

  • Solano Radiation Oncology Center

    Vacaville, California 95687
    United States

    Site Not Available

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

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • University of Florida Shands Cancer Center

    Gainesville, Florida 32610-0232
    United States

    Site Not Available

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Baptist Medical Center South

    Jacksonville, Florida 32258
    United States

    Site Not Available

  • Florida Oncology Associates at Southside Cancer Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida 32250
    United States

    Site Not Available

  • Baptist Medical Center South

    Jascksonville, Florida 32258
    United States

    Site Not Available

  • Florida Oncology Associates

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Florida Cancer Center - Palatka

    Palatka, Florida 32177
    United States

    Site Not Available

  • Flagler Cancer Center

    Saint Augustine, Florida 32086
    United States

    Site Not Available

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

    Tampa, Florida 33612-9497
    United States

    Site Not Available

  • John B. Amos Cancer Center

    Columbus, Georgia 31904
    United States

    Site Not Available

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • Eureka Community Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • McDonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • BroMenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Site Not Available

  • OSF St. Francis Medical Center

    Peoria, Illinois 61615-7827
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Community Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • St. Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • Valley Cancer Center

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • McFarland Clinic, PC

    Ames, Iowa 50010
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas 66720
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas 67801
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas 67068
    United States

    Site Not Available

  • Southwest Medical Center

    Liberal, Kansas 67901
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas 67357
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas 67124
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas 67042
    United States

    Site Not Available

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas 66604
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas 67152
    United States

    Site Not Available

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas 67203
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Wesley Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas 67156
    United States

    Site Not Available

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • West Michigan Cancer Center

    Kalamazoo, Michigan 49007-3731
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • St. John's Regional Health Center

    Springfield, Missouri 65804
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • Deaconess Billings Clinic - Downtown

    Billings, Montana 59107-7000
    United States

    Site Not Available

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska 68848-1990
    United States

    Site Not Available

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

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

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

    Vineland, New Jersey 08360
    United States

    Site Not Available

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York 14621
    United States

    Site Not Available

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Akron City Hospital

    Akron, Ohio 44309-2090
    United States

    Site Not Available

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Case Comprehensive Cancer Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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

    Salem, Ohio 44460
    United States

    Site Not Available

  • Cancer Treatment Center

    Wooster, Ohio 44691
    United States

    Site Not Available

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania 19107-5541
    United States

    Site Not Available

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Reading Hospital and Medical Center

    Reading, Pennsylvania 19612-6052
    United States

    Site Not Available

  • Guthrie Cancer Center at Guthrie Clinic Sayre

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Rapid City Regional Hospital

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Latter Day Saints Hospital

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • Theda Care Cancer Institute

    Appleton, Wisconsin 54911
    United States

    Site Not Available

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin 54307-3508
    United States

    Site Not Available

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin 54143
    United States

    Site Not Available

  • Community Memorial Hospital Cancer Care Center

    Menomonee Falls, Wisconsin 53051
    United States

    Site Not Available

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin 54401
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.