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



Status:Completed
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/20/2018
Start Date:July 1994
End Date:May 21, 2018

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Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas

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.

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.

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
We found this trial at
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Temple, Texas 76508
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
898
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
841
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
574
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
607
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
884
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Greenville, SC
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
3717
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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1177
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
1179
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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1307
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Albuquerque, New Mexico 87108
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Albuquerque, New Mexico 87131
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Ann Arbor, Michigan 48106
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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Atlanta, Georgia 30342
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Charleston, South Carolina 29401
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Cincinnati, Ohio 45220
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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400 E Third Street
Duluth, Minnesota 55805
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Fort Gordon, Georgia 30905
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600
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
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Kansas City, Kansas 66160
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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Mobile, Alabama 36688
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New Orleans, Louisiana 70112
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
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1290
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400 30th Street, Suite 301
Oakland, California 94609
(510) 465-8016
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Oklahoma City, Oklahoma 73104
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Portland, Oregon 97239
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
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3437 Caroline Mall
Saint Louis, Missouri 63110
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Saint Louis, Missouri 63141
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500 Foothill Drive
Salt Lake City, Utah 84148
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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9040 Jackson Ave
Tacoma, Washington 98431
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