Your session is about to expire
← Back to Search
Stereotactic Radiosurgery Before or After Surgery for Brain Metastasis
Phase 3
Recruiting
Led By Elizabeth Yan, M.D.
Research Sponsored by Mayo Clinic
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 (PS) =< 2
Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial looks at the side effects and efficacy of using stereotactic radiosurgery to treat brain tumors before or after surgery.
Who is the study for?
This trial is for adults over 18 with certain types of cancer that have spread to the brain and are candidates for surgery. They must be able to consent, have a performance status indicating they can handle daily activities, agree to follow-up visits, and not be pregnant or nursing. Those unwilling to use contraception or who are immunocompromised due to HIV treatment are excluded.Check my eligibility
What is being tested?
The study is testing whether stereotactic radiosurgery (SRS), a precise high-dose radiation therapy, is more effective before or after surgical removal of brain tumors in patients with metastatic cancer. It aims to see if SRS results in less damage to healthy tissue compared to traditional methods.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation such as headaches, nausea, hair loss at the treatment site, fatigue, and skin irritation. There may also be risks associated with surgery like infection and bleeding.
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...
I am recommended for brain surgery to remove a tumor based on a neurosurgeon's advice.
Select...
I am 18 years old or older.
Select...
My cancer has spread to my brain, confirmed by tests and my medical history.
Select...
I am planned for a targeted brain radiation treatment for 10 or fewer metastases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Central nervous system (CNS) composite endpoint event (CNS-CE event)
Secondary outcome measures
CNS-CE event free rate
CNS-CE event free survival time adjusted for stratification factors
Incidence of adverse events
+8 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%
Watering eyes
8%
Wheezing
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%
Skin infection
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Sore throat
4%
Urinary tract 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
Active Control
Group I: Arm B (Pre-operative SRS)Experimental Treatment4 Interventions
Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.
Group II: Arm A (Post-operative SRS)Active Control4 Interventions
Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Conventional Surgery
2006
Completed Phase 3
~1080
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,714 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,898 Total Patients Enrolled
Elizabeth Yan, M.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is suspected to be a germ cell tumor, small cell carcinoma, or lymphoma.My cancer has spread to the lining of my brain and spinal cord.I need surgery to remove two or more brain tumors.I need long-term steroids or bevacizumab treatment.I am of childbearing age and do not plan to use birth control.I am HIV positive but not immunocompromised, or I am immunocompromised.I have more than 10 brain metastases.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My brain cancer is near the optic nerve.I have had brain surgery for cancer before.I agree to follow-up visits or to send in MRI images and notes as required.I can take care of myself but might not be able to do heavy physical work.I am recommended for brain surgery to remove a tumor based on a neurosurgeon's advice.I am currently breastfeeding.I am 18 years old or older.I have had whole brain radiation therapy.I have a brain tumor larger than 5 cm.My cancer has spread to my brain, confirmed by tests and my medical history.I am planned for a targeted brain radiation treatment for 10 or fewer metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Post-operative SRS)
- Group 2: Arm B (Pre-operative SRS)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Are there still vacancies in this clinical trial for people who want to participate?
"That is correct, the clinicaltrials.gov website lists this study as recruiting. The study was first posted on November 19th, 2018 and updated as recently as February 2nd, 2022. They are looking for a total of 140 participants at 3 sites."
Answered by AI
Has the FDA cleared Stereotactic Radiosurgery for use?
"Like other Phase 3 trials, there is some data supporting the efficacy of Stereotactic Radiosurgery, as well as multiple rounds of data affirming its safety. Therefore, our team has given it a rating of 3."
Answered by AI
How many people fit the requirements for this clinical trial?
"This study needs a total of 140 patients that fit the specified enrollment requirements. Those who are interested in participating can do so at multiple locations, such as Mayo Clinic in Arizona in Scottsdale, Arizona and Mayo Clinic in Florida in Jacksonville, Florida."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger