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Pre-Surgical Radiosurgery for Brain Metastases
Phase < 1
Recruiting
Led By Zachary Buchwald, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is to see if there are side effects from giving stereotactic radiosurgery to patients with brain metastases before surgery. Radiation may stimulate an anti-tumor immune response.
Who is the study for?
This trial is for adults over 18 with cancer that has spread to the brain, visible on MRI. They must have a life expectancy of more than 12 weeks, be able to undergo surgery, and follow study procedures. Pregnant or nursing women, those on immunosuppressants (except dexamethasone), or with certain serious illnesses can't participate.Check my eligibility
What is being tested?
The trial tests if stereotactic radiosurgery before surgery can prevent cancer from returning in patients with brain metastases. It's an early phase I trial focused on understanding side effects and how well this pre-surgery radiation works as a treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions to radiation like headaches, nausea, fatigue, hair loss at the treatment site, and skin irritation. Surgery risks include bleeding, infection, and reactions to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My doctor says my body is strong enough for surgery.
Select...
I am 18 years old or older.
Select...
I have or might have had cancer before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events grade 3 or greater
Secondary outcome measures
Density of immune niche in brain metastases
Overall survival (OS)
Time to anywhere brain failure (ABF)
+1 moreSide effects data
From 2019 Phase 2 trial • 32 Patients • NCT0157370232%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Myalgia
8%
Wheezing
8%
Watering eyes
8%
Urinary tract pain
8%
Weight loss
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Sore throat
4%
Urinary tract infection
4%
Skin infection
4%
Lethargy
4%
Infusion site extravasation
4%
Urinary urgency
4%
Vomiting
4%
Insomnia
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (SRS, high dose dexamethasone, surgery)Experimental Treatment2 Interventions
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
Group II: Arm A (SRS, low dose dexamethasone, surgery)Experimental Treatment3 Interventions
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Resection
2021
Completed Phase 2
~410
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,512 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,501 Total Patients Enrolled
Zachary Buchwald, MD, PhDPrincipal Investigator - Emory University Hospital/Winship Cancer Institute
Emory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's schedule and procedures.I can take care of myself but might not be able to do heavy physical work.My doctor says my body is strong enough for surgery.I am taking immunosuppressive medication, but not dexamethasone.I am 18 years old or older.I have had brain radiation or surgery at the same spot that is now planned for surgery.I have or might have had cancer before.I am not pregnant and am using birth control or cannot become pregnant due to surgery.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (SRS, high dose dexamethasone, surgery)
- Group 2: Arm A (SRS, low dose dexamethasone, surgery)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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.
What conditions are commonly treated with Stereotactic Radiosurgery?
"Stereotactic Radiosurgery is an effective treatment option for ophthalmia, sympathetic and other ailments like eye branch retinal vein occlusion as well as macular edema."
Answered by AI
What have been the outcomes of prior experimentation with Stereotactic Radiosurgery?
"Currently, 552 medical trials related to Stereotactic Radiosurgery are running in the United States. Of these studies, 143 have advanced as far as Phase 3 while 18649 locations host them. Billings, Montana is a notable site for this treatment's exploration."
Answered by AI
How many participants are presently involved in this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov affirms that the recruitment process for this research is ongoing, having first been published on July 20th 2021 and last updated August 29th 2022. Currently, the program seeks to onboard up to 20 individuals from a single site."
Answered by AI
Are individuals currently being recruited for involvement in this trial?
"As indicated on clinicaltrials.gov, this medical trial is open for enrolment. This research was first publicized on July 20th 2021 and the information has been refreshed as of August 29th 2022."
Answered by AI
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