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Radiation Therapy
Single vs Multiple Dose Radiation for Brain Metastases (HYPOGRYPHE Trial)
N/A
Recruiting
Led By Christina K Cramer, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Summary
This trial evaluates if a lower radiation dose over multiple days reduces side effects vs. one day of full radiation dose for cancer patients on immunotherapy.
Who is the study for?
This trial is for adults with certain cancers (melanoma, kidney, non-small cell lung cancer, or breast cancer) that have spread to the brain. They must have at least one brain tumor of a specific size and are on or will be on immunotherapy. Pregnant women and those who can't undergo MRI scans are excluded.
What is being tested?
The study compares two types of radiation treatments for patients with brain metastases from certain cancers also receiving immunotherapy: a single high-dose session versus multiple lower-dose sessions over several days to see which better reduces side effects.
What are the potential side effects?
Potential side effects may include fatigue, headaches, hair loss at the treatment site, nausea, skin irritation around the treated area, and in rare cases swelling or more serious complications within the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of a Grade 2 or higher Adverse Radiation Effect (ARE)
Secondary study objectives
Compare patient-reported brain tumor specific symptom burden
Compare time to composite end point
Compare time to local failure between SSRS and FSRS groups
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FSRS = fractionated stereotactic radiosurgeryExperimental Treatment1 Intervention
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.
Group II: SSRS = single fraction stereotactic radiosurgeryActive Control1 Intervention
SSRS is an advanced radiation technique that delivers high dose precision radiation in a single dose to discrete intracranial lesions. SSRS has recently become a standard-of-care treatment for patients with 1-4 brain metastases and is also commonly used for patients with up to 15 metastases, due to improved neurocognitive outcomes compared to whole brain radiotherapy.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,756 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,463 Total Patients Enrolled
Christina K Cramer, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had radiation for brain tumors, but they were treated far from where my current cancer would be targeted.I have had brain radiation therapy before.I am 18 years old or older.I have 15 or fewer brain tumors suitable for specific radiation treatments.My brain cancer is very close to my optic nerves.My lesion's size was estimated using a specific MRI technique.My cancer has spread to the lining of my brain or spinal cord, confirmed by tests.I have a brain tumor larger than 2 cm or 4 cc and haven't had brain radiation before.My tumor's total size is 30 cc or less, measured by MRI or treatment software.I cannot undergo an MRI with contrast for my brain.My cancer is either melanoma, kidney, lung, or breast cancer.I can do most of my daily activities by myself.My cancer has spread outside the brain and does not need to be under control to join.I have brain metastases and may or may not have received systemic therapy for it.I am undergoing or will undergo therapy targeting my immune system within 30 days.I have not taken bevacizumab within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: FSRS = fractionated stereotactic radiosurgery
- Group 2: SSRS = single fraction stereotactic radiosurgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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