Phase III Trial of Anaplastic Glioma Without 1p/19q LOH



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:7/28/2017
Start Date:December 2007
End Date:January 2024

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Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving radiation therapy
together with temozolomide may kill more tumor cells. It is not yet known whether giving
temozolomide during and/or after radiation therapy is more effective than radiation therapy
alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after
radiation therapy to see how well it works compared to radiation therapy alone in treating
patients with anaplastic glioma.

OBJECTIVES:

Primary

- To assess whether concurrent radiotherapy with daily temozolomide improves overall
survival as compared to no daily temozolomide in patients with non-1p/19q deleted
anaplastic glioma.

- To assess whether adjuvant temozolomide improves survival as compared to no adjuvant
temozolomide in patients with non-1p/19q deleted anaplastic glioma.

Secondary

- To assess whether concurrent and adjuvant temozolomide prolongs progression-free
survival and neurological deterioration-free survival in patients with non-1p/19q
deleted anaplastic glioma.

- To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q
deleted anaplastic glioma, including late effects on cognition.

- To assess the impact of concurrent and adjuvant temozolomide on the quality of life of
patients with non-1p/19q deleted anaplastic glioma.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO
performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no),
presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase
promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are
randomized to 1 of 4 treatment arms.

- Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of
33 fractions).

- Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral
temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).

- Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total
of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive
adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide
repeats every 28 days for up to 12 courses.

- Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral
temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy). Beginning
4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide
once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for
up to 12 courses.

NOTE: *Patients must begin radiotherapy within 8 days after randomization and within 7 weeks
after surgery.

In all arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Patients complete quality-of-life questionnaires, including QLQ-C30 version 3, BCM20, and the
Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then
every 3 months for 5 years.

Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation
status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase
mutation analysis.

After completion of study treatment, patients are followed every 3 months.

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Anaplastic oligodendroglioma

- Anaplastic oligoastrocytoma

- Anaplastic astrocytoma

- Newly diagnosed disease

- Prior surgery for a low grade tumor is allowed, provided histological confirmation of
an anaplastic tumor is present at the time of progression

- Absence of combined 1p/19q loss

- Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA
methyltransferase promoter methylation status assessment, isocitrate dehydrogenase
mutation analysis, and central pathology review

- Patients must be on a stable or decreasing dose of steroids for at least two weeks
prior to randomization

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- ANC ≥ 1.5 x 10^9 cells/L

- Platelet count ≥ 100 x 10^9 cells/L

- Bilirubin < 1.5 x upper limit of normal (ULN)

- Alkaline phosphatase < 2.5 x ULN

- AST and ALT < 2.5 x ULN

- Serum creatinine < 1.5 x ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No known HIV infection or chronic hepatitis B or hepatitis C infection

- No other serious medical condition that would interfere with follow-up

- No medical condition that could interfere with oral medication intake (e.g., frequent
vomiting or partial bowel obstruction)

- No other prior malignancies except for any malignancy which was treated with curative
intent more than 5 years prior to registration and adequately controlled limited basal
cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ
of the cervix

- No prior or concurrent malignancies at other sites except for surgically cured
carcinoma in situ of the cervix or nonmelanoma skin cancer

- No psychological, familial, sociological, or geographical condition that would
potentially hamper compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy, including carmustine-containing wafers (Gliadel®)

- No prior radiotherapy to the brain

- No concurrent growth factors unless vital for the patient

- No other concurrent investigational treatment

- No other concurrent anticancer agents
We found this trial at
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
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201 Dowman Dr
Atlanta, Georgia 30303
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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301 University Blvd
Galveston, Texas 77555
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900 West Faris Road
Greenville, South Carolina 29605
(864) 679-3900
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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131 Lila Doyle Drive
Seneca, South Carolina 29672
(864) 888-3717
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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Ames, Iowa 50010
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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155 5th St NE
Barberton, Ohio 44203
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Boston, Massachusetts 02118
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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303 East Superior Street
Chicago, Illinois 60611
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2049 E 100th St
Cleveland, Ohio 44106
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2500 Metrohealth Dr
Cleveland, Ohio 44109
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Fort Wayne, Indiana 46805
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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1726 Shawano Ave
Green Bay, Wisconsin 54303
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Greenville, South Carolina 29615
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Indianapolis, Indiana 46260
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
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1900 South Ave
La Crosse, Wisconsin 54601
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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2160 South 1st Avenue
Maywood, Illinois 60153
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
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8303 Dodge St
Omaha, Nebraska 68114
(402) 354-8124
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3909 Orange Place
Orange, Ohio 44122
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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Phoenix, Arizona 85013
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Richmond, Virginia 23298
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Rochester, New York 14620
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621 South New Ballas Road
Saint Louis, Missouri 63141
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8th Ave & C St
Salt Lake City, Utah 84143
(801) 408-1100
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4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
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Scarborough, Maine 04074
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Seattle, Washington 98101
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Sioux City, Iowa 51101
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
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St. Leonards, New South Wales 2065
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Waukesha, Wisconsin 53188
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West Reading, Pennsylvania 19612
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Westlake, Ohio 44145
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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
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550 N Hillside St
Wichita, Kansas 67214
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Wooster, Ohio 44691
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