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Radiation Therapy
Stereotactic Radiosurgery for Brain Cancer
N/A
Recruiting
Led By Michael Straza, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects, even if surgically sterilized, who agree to specific contraceptive methods
Surgical resection able to be performed within 1-10 days after radiosurgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for brain metastases in 10 patients.
Who is the study for?
This trial is for adults with 1-4 brain metastases who can undergo stereotactic radiosurgery and surgical resection. They must have had a recent MRI, not be on anti-VEGF therapy, and have an estimated survival of at least 6 months. Women must use contraception or be postmenopausal; men agree to barrier contraception.Check my eligibility
What is being tested?
The study tests preoperative stereotactic radiosurgery using Gamma Knife Icon in patients with brain metastases. It's a pilot study enrolling 10 patients to see how well they do when surgery follows within 1-10 days after the radiosurgery.See study design
What are the potential side effects?
Potential side effects include those typical of radiation treatments such as headaches, nausea, fatigue, hair loss at treatment site, swelling or bruising of the brain tissue around the treated area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man willing to use contraception as required.
Select...
I can have surgery 1-10 days after my radiosurgery.
Select...
My cancer has spread to my brain, confirmed by imaging tests.
Select...
My brain scan shows 1-4 solid tumor metastases, and the largest is no bigger than 5 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects undergoing resection following SRS.
The number of subjects with no identifiable disease following resection.
Secondary outcome measures
The number of subjects achieving CNS progression-free survival.
The number of subjects achieving overall survival.
The number of subjects reporting a high quality of life.
+2 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
1Treatment groups
Experimental Treatment
Group I: Stereotactic RadiosurgeryExperimental Treatment1 Intervention
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,568 Total Patients Enrolled
Michael Straza, MDPrincipal InvestigatorMedical College of Wisconsin
Joseph Bovi, MD5.02 ReviewsPrincipal Investigator - Medical College of Wisconsin
Medical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery cannot be scheduled within 1 to 10 days after my radiosurgery.My doctor estimates I have less than 6 months to live based on my cancer type.My doctor thinks I am a good candidate for a precise radiation treatment.I haven't taken anti-VEGF therapy in the last 6 weeks.The area needing surgery is larger than 5 cm.A neurosurgeon has determined I cannot have surgery.I am currently on chemotherapy or immunotherapy, but not on anti-VEGF therapy.I am a man willing to use contraception as required.I am 18 years old or older.My cancer has spread to the lining of my brain or spinal cord.A neurosurgeon has approved me for surgery to remove at least one cancer spread.The lesion to be removed has been treated with radiation before.I can have surgery 1-10 days after my radiosurgery.I have had whole brain radiation therapy before.I am scheduled for targeted brain radiation therapy after my main treatment.I am a woman who is either postmenopausal, surgically sterile, or using birth control.My cancer has spread to my brain, confirmed by imaging tests.My brain scan shows 1-4 solid tumor metastases, and the largest is no bigger than 5 cm.My doctor has decided I am not a candidate for a specific type of radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Are there any openings remaining for participants in this trial?
"Correct. Clinicaltrials.gov showcases that this clinical trial remains open for recruitment, commencing on the fifteenth of January 2021 and last updated on March 2nd 2022."
Answered by AI
How many participants are involved in the clinical investigation?
"Affirmative. Clinicaltrials.gov's records disclose that this clinical trial, initially published on January 15th 2021, is currently recruiting participants. The study calls for 10 volunteers from a single site to join the research effort."
Answered by AI
What is the ultimate objective of this investigation?
"The primary metric of success for this trial, monitored over a period of 20 months, is the number patients who undergo resection post SRS. Secondary assessments include amount of subjects with radiation necrosis (as evidenced on MRI), overall survival rate at 6, 12 and 18 month intervals following surgery, as well as CNS progression-free survivability determined using RANO-BM criteria across the same time frames."
Answered by AI
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