Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

Last updated: June 15, 2018
Sponsor: Radiation Therapy Oncology Group
Overall Status: Completed

Phase

3

Condition

Oligodendroglioma

Treatment

N/A

Clinical Study ID

NCT00002569
RTOG-9402
SWOG-9402
CAN-NCIC-CE2
INT-0149
CDR0000063603
E-R9402
NCCTG-927252
  • Ages > 18
  • All Genders

Study Summary

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 with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma

  • Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma

  • Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation

  • For mixed tumors, the non-oligodendroglial element must be astrocytic and the oligodendroglial or astroglial component may be anaplastic

  • No evidence of spinal drop metastasis or spread to noncontiguous meninges

  • MRI of spine not required for asymptomatic patients and patients not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor

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

  • No spinal cord tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3

  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times normal

  • Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal

  • Alkaline phosphatase no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Pulmonary:

  • No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO) is at least 60% predicted

Other:

  • No active infection

  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No concurrent steroids as antiemetics

  • Concurrent steroids allowed to control central nervous system (CNS) symptoms due to tumor-associated or radiotherapy-associated cerebral edema

Radiotherapy:

  • No prior radiotherapy to brain or head/neck

Surgery:

  • Prior surgery allowed

Study Design

Total Participants: 299
Study Start date:
July 01, 1994
Estimated Completion Date:
May 21, 2018

Study Description

OBJECTIVES:

  • Compare the overall survival and time to tumor progression in patients with unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with radiotherapy with or without procarbazine, lomustine, and vincristine (PCV).

  • Compare the toxic effects of these 2 regimens in these patients.

  • Compare the quality of life and neurologic function of patients treated with these 2 regimens.

OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment continues every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a week for 1 week.

  • Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I.

Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of study therapy.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study within 5.4 years.

Connect with a study center

  • MBCCOP - Gulf Coast

    Mobile, Alabama 36688
    United States

    Site Not Available

  • CCOP - Greater Phoenix

    Phoenix, Arizona 85006-2726
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona 85723
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California 91010-3000
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California 90033-0804
    United States

    Site Not Available

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California 90073
    United States

    Site Not Available

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California 94553
    United States

    Site Not Available

  • CCOP - Bay Area Tumor Institute

    Oakland, California 94609-3305
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California 94143-0128
    United States

    Site Not Available

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California 95403
    United States

    Site Not Available

  • David Grant Medical Center

    Travis Air Force Base, California 94535
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80010
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado 80220
    United States

    Site Not Available

  • CCOP - Atlanta Regional

    Atlanta, Georgia 30342-1701
    United States

    Site Not Available

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia 30905-5650
    United States

    Site Not Available

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii 96813-2424
    United States

    Site Not Available

  • Tripler Army Medical Center

    Honolulu, Hawaii 96859-5000
    United States

    Site Not Available

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois 60612-7323
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois 60141
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7353
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas 67218
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky 40502-2236
    United States

    Site Not Available

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana 71130-3932
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts 02130
    United States

    Site Not Available

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-0912
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201-1379
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan 48201-1932
    United States

    Site Not Available

  • Providence Hospital - Southfield

    Southfield, Michigan 48075-9975
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi 39531-2410
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler AFB, Mississippi 39534-2576
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi 39534-2576
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • CCOP - St. Louis-Cape Girardeau

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St. Louis University Health Sciences Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri 65807
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico 87108-5138
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albany

    Albany, New York 12208
    United States

    Site Not Available

  • Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina 27104-4241
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45267-0501
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio 45220-2288
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43206
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio 45428
    United States

    Site Not Available

  • CCOP - Dayton

    Kettering, Ohio 45429
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio 43623-3456
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • CCOP - Columbia River Program

    Portland, Oregon 97225
    United States

    Site Not Available

  • OHSU Cancer Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon 97207
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-0721
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina 29401-5799
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234-6200
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0565
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    Lubbock, Texas 79415
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78284-7845
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas 78284
    United States

    Site Not Available

  • CCOP - Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Temple

    Temple, Texas 76504
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112-5550
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • CCOP - Virginia Mason Research Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington 98108
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431-5048
    United States

    Site Not Available

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