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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
Must not have
Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma
Leptomeningeal metastasis/disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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 below
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I can take care of myself but might not be able to do heavy physical work.
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I am recommended for brain surgery to remove a tumor based on a neurosurgeon's advice.
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I am 18 years old or older.
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My cancer has spread to my brain, confirmed by tests and my medical history.
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I am planned for a targeted brain radiation treatment for 10 or fewer metastases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is suspected to be a germ cell tumor, small cell carcinoma, or lymphoma.
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My cancer has spread to the lining of my brain and spinal cord.
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My brain cancer is near the optic nerve.
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I need surgery to remove two or more brain tumors.
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I need long-term steroids or bevacizumab treatment.
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I am of childbearing age and do not plan to use birth control.
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I have more than 10 brain metastases.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have had brain surgery for cancer before.
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I am currently breastfeeding.
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I have had whole brain radiation therapy.
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I have a brain tumor larger than 5 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Central nervous system (CNS) composite endpoint event (CNS-CE event)
Secondary study objectives
CNS-CE event free rate
CNS-CE event free survival time adjusted for stratification factors
Incidence of adverse events
+8 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702
32%
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%
Urinary tract pain
8%
Weight loss
8%
Watering eyes
8%
Wheezing
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Sore throat
4%
Vomiting
4%
Urinary urgency
4%
Urinary tract infection
4%
Upper respiratory infection
4%
Skin infection
4%
White blood cell decreased
4%
Insomnia
4%
Lethargy
4%
Infusion site extravasation
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

Awards & Highlights

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.

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
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,325 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,035 Total Patients Enrolled
Elizabeth Yan, M.D.Principal InvestigatorMayo Clinic

Media Library

Conventional Surgery Clinical Trial Eligibility Overview. Trial Name: NCT03750227 — Phase 3
Brain Metastasis Research Study Groups: Arm A (Post-operative SRS), Arm B (Pre-operative SRS)
Brain Metastasis Clinical Trial 2023: Conventional Surgery Highlights & Side Effects. Trial Name: NCT03750227 — Phase 3
Conventional Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT03750227 — Phase 3
~19 spots leftby Nov 2025
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