← Back to Search

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
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,839 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,401 Previous Clinical Trials
2,460,061 Total Patients Enrolled
Christina K Cramer, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

FSRS (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05703269 — N/A
Small Cell Lung Cancer Research Study Groups: FSRS = fractionated stereotactic radiosurgery, SSRS = single fraction stereotactic radiosurgery
Small Cell Lung Cancer Clinical Trial 2023: FSRS Highlights & Side Effects. Trial Name: NCT05703269 — N/A
FSRS (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703269 — N/A
~163 spots leftby Mar 2028