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A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

Cancer Type
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Supportive care
Protocol IDs
WF-1801 (primary)
Study Sponsor
Wake Forest NCORP Research Base


This phase II trial studies how well ramipril works in preventing cognitive decline in patients with glioblastoma or gliosarcoma who are undergoing brain radiation therapy and chemotherapy with temozolomide. Adding ramipril to standard of care treatment may help to lower the chance of memory loss.


I. To assess the retention rate of patients at 10 weeks of ramipril treatment (6 weeks during radiation therapy [RT] and 4 weeks post RT) to determine whether or not we should proceed to a subsequent randomized study.
II. To estimate the effect of 10 weeks of ramipril on neurocognitive function in patients with glioblastoma (GBM) receiving chemoradiotherapy.

I. To estimate the time to neurocognitive decline with GBM receiving chemoradiotherapy and ramipril.
II. To estimate the effect of treatment with ramipril on and variability of specific non-memory cognitive functions including attention, executive function, visuo-motor skills, working memory, a screening measure of global cognitive function, mood, quality of life, fatigue and sleep disturbance.
III. To collect preliminary data on the presence of apolipoprotein epsilon (ApoE) isoform 4 serum (peripheral blood lymphocyte) test positivity as measured by quantitative polymerase chain reaction (PCR).
IV. To estimate neurocognitive function in surviving patients at the 4 month post RT endpoint.
V. To estimate response as reported by treating physician assessments.

I. To explore any subgroup differences for all secondary objectives measured at the post-RT 4 month visit by whether the patient received Optune (also known as Tumor-Treating Fields or TTFields) as part of their standard treatment following RT.

Beginning with standard of care RT and chemotherapy with temozolomide, patients receive ramipril orally (PO) once daily (QD) for 22 weeks (4 months post RT) in the absence of disease progression or unacceptable toxicity. After 1 month post RT, use of the Optune device may be used at the discretion of the treating physicians as per standard of care guidelines, timing and training.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342

Atlanta Gynecologic Oncology

980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033

Georgia Gynecologic Oncology

980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342

Northside Hospital Cancer Institute - Forsyth

1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041

University Gynecologic Oncology

960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofitthat leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.