RecruitingNot ApplicableNCT05703269

Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy

Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE)


Sponsor

Wake Forest University Health Sciences

Enrollment

244 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to see if we can lower the chance of side effects from radiation in patients with breast, kidney, small cell lung cancer, non-small cell lung cancer or melanoma that has spread to the brain and who are also being treated with immunotherapy, specifically immune checkpoint inhibitor (ICI) therapy. This study will compare the usual care treatment of single fraction stereotactic radiosurgery (SSRS) given on one day versus fractionated stereotactic radiosurgery (FSRS), which is a lower dose of radiation given over a few days to determine if FSRS is better or worse at reducing side effects than usual care treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation approaches for cancer patients with brain metastases (tumors that have spread to the brain) who are also receiving immunotherapy: one large, single dose of radiation versus several smaller doses spread over multiple visits. **You may be eligible if...** - You are 18 or older - You have at least one brain metastasis that is 2 cm or larger in diameter - You have 15 or fewer brain metastases in total - You are receiving immunotherapy for your cancer - You have had a brain MRI to confirm the metastases **You may NOT be eligible if...** - You need re-irradiation of a previously treated brain lesion - Your brain metastases are not visible or measurable on MRI - You are unable to undergo radiation treatment safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONsingle fraction stereotactic radiosurgery (SSRS)

SSRS is an advanced radiation technique that delivers high dose precision radiation in a single dose to discrete intracranial lesions.

RADIATIONfractionated stereotactic radiosurgery (FSRS)

FSRS is an advanced radiation technique that uses a lower dose precision radiation delivered over 3 to 5 treatments given daily or every other day to intracranial lesions.


Locations(39)

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Overlook Medical Center

Summit, New Jersey, United States

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, United States

Lovelace Radiation Oncology

Albuquerque, New Mexico, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Aspirus Langlade Hospital

Antigo, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05703269


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