Last updated on June 2019

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery


Brief description of study

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine, in terms of progression-free survival (PFS), the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.

SECONDARY OBJECTIVES:

I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Outcomes and patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Tissue microarray construction, and assessment of pHH3 mitotic index and molecular correlates to OS.

OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection.

ARM I: Patients undergo observation.

ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each).

After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

Clinical Study Identifier: NCT03180268

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Piedmont Hospital

Atlanta, GA United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Decatur Memorial Hospital

Decatur, IL United States
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Florida Hospital Orlando

Orlando, FL United States
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Mayo Clinic Hospital

Phoenix, AZ United States
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Mayo Clinic in Arizona

Scottsdale, AZ United States
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Memorial Medical Center

Modesto, CA United States
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Rohnert Park Cancer Center

Rohnert Park, CA United States
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South Sacramento Cancer Center

Sacramento, CA United States
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Kaiser Permanente Cancer Treatment Center

South San Francisco, CA United States
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Hartford Hospital

Hartford, CT United States
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Yale University

New Haven, CT United States
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Beebe Health Campus

Rehoboth Beach, DE United States
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Nanticoke Memorial Hospital

Seaford, DE United States
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Boca Raton Regional Hospital

Boca Raton, FL United States
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Miami Cancer Institute

Miami, FL United States
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AdventHealth Orlando

Orlando, FL United States
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Moffitt Cancer Center

Tampa, FL United States
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Grady Health System

Atlanta, GA United States
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Queen's Medical Center

Honolulu, HI United States
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Northwestern University

Chicago, IL United States
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University of Illinois

Chicago, IL United States
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IU Health Methodist Hospital

Indianapolis, IN United States
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Saint Joseph Mercy Hospital

Ann Arbor, MI United States
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Saint Joseph Mercy Chelsea

Chelsea, MI United States
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Saint Mary Mercy Hospital

Livonia, MI United States
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Mayo Clinic

Rochester, MN United States
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University of Rochester

Rochester, NY United States
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ProMedica Flower Hospital

Sylvania, OH United States
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UHHS-Westlake Medical Center

Westlake, OH United States
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Geisinger Medical Center

Danville, PA United States
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Lankenau Medical Center

Wynnewood, PA United States
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M D Anderson Cancer Center

Houston, TX United States
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Norris Cotton Cancer Center-North

Saint Johnsbury, VT United States
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Legacy Salmon Creek Hospital

Vancouver, WA United States
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Community Memorial Hospital

Menomonee Falls, WI United States
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Recruitment Status: Open


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