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

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT03180268
Trial Phases:	Phase III	Protocol IDs:	NRG-BN003 (primary) NCI-2016-01619
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT03180268

Summary

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.

Objectives

PRIMARY OBJECTIVE:
I. To determine 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. Assessment of pHH3 mitotic index and its correlation with progression-free survival (PFS) and OS.
IX. Tissue and specimen collection for future translational research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo observation.

ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity.

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.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Atlanta Cancer Care - Conyers
1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Cumming
1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
404-303-3355
www.atlantacancercare.com

Doctors:

Amelia B. Zelnak MD

Kelly A. May MD

Atlanta Cancer Care - Decatur
2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Stockbridge
7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD

Lijo Simpson MD

Atlanta Cancer Care - Tower
5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Doctors:

Amelia B. Zelnak MD

Kelly A. May MD

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Georgia Cancer Specialists - Athens
125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Doctors:

Ranjana S. Bhargava MD

Priya Rudolph

Georgia Cancer Specialists - Canton
228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Doctors:

Louis Crain Garrot MD

Gena H. Volas-Redd MD

Lynn M. Zemsky MD

Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD

Nishan H. Fernando MD

Pradeep C. Jolly MD

Georgia Cancer Specialists - Decatur
2712 Lawrenceville Highway
Decatur, GA 30033
404-303-3355
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD

Aaron R. Alizadeh MD

Georgia Cancer Specialists - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Doctors:

Louis Crain Garrot MD

Gena H. Volas-Redd MD

Lynn M. Zemsky MD

Georgia Cancer Specialists - Macon-Coliseum
308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD

Premila Malhotra MD

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:

404-303-3355

Doctors:

Rodolfo E. Bordoni MD

Louis Crain Garrot MD

Pradeep C. Jolly MD

Cheryl F. Jones MD

Gurinderjit K. Sidhu MD

Jayanthi Srinivasiah MD

Gena H. Volas-Redd MD

Nancy H. Wiggers MD

Amelia B. Zelnak MD

Simbo O. Aduloju MD

Premila Malhotra MD

Aaron R. Alizadeh MD

Kelly A. May MD

Edmund Simon MD

Ranjana S. Bhargava MD

Priya Rudolph

Kathleen E. Lambert MD

Piedmont Fayette Hospital
1255 Highway 54 West
Fayetteville, GA 30214
404-851-2340
www.piedmont.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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