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

Status
Active
Cancer Type
Brain & Spinal Cord Tumor
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03180268
Protocol IDs
NRG-BN003 (primary)
NCI-2016-01619
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


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

Doctors:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Ronald G. Steis MD

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
Renee Gaiter
770-205-5292 x1041
www.atlantacancercare.com

Doctors:

Sreekanth C. Reddy MD
Ronald G. Steis MD
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

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge
7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
Andrena Jefferson
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:

Colleen S. Austin MD
Silpa C. Reddy MD
Sreekanth C. Reddy MD
Amelia B. Zelnak MD
Kelly A. May MD

Georgia Cancer Specialists - Athens
125 King Avenue
Suite 200
Athens, GA 30606
Cynthia Pirkle
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
Anila Lokhandwala
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Nishan H. Fernando MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
Greta Dudley
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
Sonia Hernandez
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Georgia Cancer Specialists - Stemmer
2712 Lawrenceville Highway
Decatur, GA 30033
Nina Patel
770-496-5555
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD
Simbo O. Aduloju MD
Aaron R. Alizadeh MD
Kathleen E. Lambert MD

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
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

Northside Hospital Cancer Institute - Forsyth
1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041
404-303-3355
www.northside.com

 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org
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