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Radiation Therapy
SSRS vs FSRS for Brain Metastasis(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
Karnofsky Performance Status (KPS) ≥ 70. Refer to Appendix A
At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume with no prior history of radiation therapy for brain metastasis
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up9 months
Awards & highlights
No Placebo-Only Group
HYPOGRYPHE Trial 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.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Breast Cancer
- Melanoma
- Brain Metastases
- Kidney Cancer
HYPOGRYPHE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must have a Karnofsky Performance Status (KPS) score of 70 or higher.
Select...
You have a brain tumor that is at least 2 cm in size or has a volume of at least 4 cc, and you have not received radiation therapy for it before.
Select...
You can participate in the study even if you have non-brain related disease, and it does not need to be controlled before joining the study.
Select...
You can participate if you have brain metastases that have been treated with systemic therapy alone.
Select...
The size of the lesion will be measured using MRI scans, and in some cases, special software will be used to calculate the total tumor volume.
Select...
You have a maximum of 15 brain metastases that can be treated with a specific type of radiation therapy at a certified facility.
Select...
The total size of all visible tumors must be less than 30 cubic centimeters. Tumor size will be measured using MRI scans or by outlining the tumors on treatment planning software. If there is a cavity, only the remaining tumor inside or near the cavity will be counted.
Select...
You can undergo an MRI brain scan with a special contrast dye called gadolinium.
Select...
You have been diagnosed with melanoma, renal cell carcinoma, non-small cell lung cancer, or breast cancer through a tissue sample test.
Select...
You have taken, are taking, or are planning to take a specific type of immune therapy within 30 days before the start of the study. If you have taken a different kind of immune therapy, you may still be eligible.
Select...
Women who can become pregnant must have a recent negative pregnancy test before joining the study.
HYPOGRYPHE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of a Grade 2 or higher Adverse Radiation Effect (ARE)
Secondary outcome measures
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
HYPOGRYPHE 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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,208 Previous Clinical Trials
1,029,885 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,489 Previous Clinical Trials
41,266,433 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:- You must have a Karnofsky Performance Status (KPS) score of 70 or higher.You have taken bevacizumab as part of your treatment within the last 30 days before starting the study.You have a brain tumor that is at least 2 cm in size or has a volume of at least 4 cc, and you have not received radiation therapy for it before.You can participate in the study even if you have non-brain related disease, and it does not need to be controlled before joining the study.You can participate if you have brain metastases that have been treated with systemic therapy alone.You have received radiation therapy to your brain in the past.You have a maximum of 15 brain metastases that can be treated with a specific type of radiation therapy at a certified facility.You had radiation therapy for brain tumors in the past, but some types of non-cancerous brain tumors may be allowed if they are far away from the area being treated in this study. The study leader or another approved person must review these cases before you can join the study.You have been diagnosed with leptomeningeal carcinomatosis through a spinal tap or MRI scan. If there are no signs of this condition, a spinal tap is not needed for eligibility confirmation.You have a brain tumor close to the nerves that connect your eyes to your brain.You can't have a brain MRI or the special dye used during the MRI.The size of the lesion will be measured using MRI scans, and in some cases, special software will be used to calculate the total tumor volume.The total size of all visible tumors must be less than 30 cubic centimeters. Tumor size will be measured using MRI scans or by outlining the tumors on treatment planning software. If there is a cavity, only the remaining tumor inside or near the cavity will be counted.You can undergo an MRI brain scan with a special contrast dye called gadolinium.You have been diagnosed with melanoma, renal cell carcinoma, non-small cell lung cancer, or breast cancer through a tissue sample test.You have taken, are taking, or are planning to take a specific type of immune therapy within 30 days before the start of the study. If you have taken a different kind of immune therapy, you may still be eligible.Women who can become pregnant must have a recent negative pregnancy test before joining the study.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are individuals being admitted for this experiment?
"Affirmative. The clinicaltrials.gov page indicates that this investigation is currently recruiting patients. It was initially posted on 11th July 2023, and the most recent update occurred on 17th July 2023. 244 participants are being sought at 1 medical centre for trial participation."
Answered by AI
Are there any possibilities to enroll in this research endeavor currently?
"Affirmative. The information on clinicaltrials.gov confirms that this research is currently seeking participants, having been first posted to the website on July 11th 2023 and last updated July 17th of the same year. 244 individuals are sought across 1 medical centre for inclusion in the trial."
Answered by AI
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