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Radiation
Stereotactic Radiosurgery for Brain Cancer (SRS Trial)
N/A
Recruiting
Led By Robert Timmerman, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have 10 or less brain metastases
Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
SRS Trial Summary
This trial is testing if higher doses of radiation can improve outcomes for people with brain metastases who have not had radiation before.
Who is the study for?
This trial is for adults with non-hematopoietic cancer and up to 10 brain metastases, none larger than 3.0 cm or in the brain stem. Participants must not be pregnant, agree to use contraception, have an ECOG score of ≤2 or Karnofsky score ≥50, and can have had prior treatments except recent brain surgery or radiation.Check my eligibility
What is being tested?
The study tests increasing doses of Stereotactic Radiosurgery (SRS) on patients who haven't received previous brain radiation. The goal is to find higher tolerable doses that could improve treatment outcomes like tumor control and patient survival.See study design
What are the potential side effects?
Potential side effects may include headaches, nausea, fatigue, hair loss at the treatment site, swelling around the treated area leading to increased intracranial pressure, hearing loss if near auditory structures and short-term memory issues.
SRS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 10 or fewer brain tumors.
Select...
My cancer is not related to blood, small cell lung, germ cell, or an unknown primary.
Select...
I can care for myself but cannot do regular physical activities without help.
Select...
I am 18 years old or older.
Select...
My largest cancer lesion is 3.0 cm or smaller.
Select...
My brain cancer has not spread to the brain stem.
SRS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal tolerated doses
Secondary outcome measures
Local progression rate
Overall survival
Response rate
+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%
Weight loss
8%
Wheezing
8%
Urinary tract pain
8%
Watering eyes
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Myalgia
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Skin infection
4%
Urinary tract infection
4%
White blood cell decreased
4%
Vomiting
4%
Sore throat
4%
Upper respiratory infection
4%
Urinary urgency
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%
Infusion site extravasation
4%
Insomnia
4%
Lethargy
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
SRS Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic RadiosurgeryExperimental Treatment1 Intervention
Radiation, Stereotactic Radiosurgery Dose-Escalation
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?
University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,415 Total Patients Enrolled
Robert Timmerman, MD4.25 ReviewsPrincipal Investigator - UTSW
University of Texas Southwestern Medical Center
4 Previous Clinical Trials
338 Total Patients Enrolled
5Patient Review
Dr. made me feel comfortable and explained things in a way that I could understand. I would definitely recommend him to others.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have 10 or fewer brain tumors.I do not have any severe illnesses that could interfere with the study.I am not pregnant or breastfeeding.My cancer is not related to blood, small cell lung, germ cell, or an unknown primary.I have brain metastasis visible on MRI or CT scans.I've had cancer treatments but not brain radiation. If I had brain surgery, it was over a week ago and I have at least one treatable brain tumor.I am a woman who can still have children and have not been through menopause.I agree to use effective birth control or abstain from sex during the study.I had brain surgery within the last week.My cancer has spread to the lining of my brain and spinal cord.I can care for myself but cannot do regular physical activities without help.I am 18 years old or older.My largest cancer lesion is 3.0 cm or smaller.My brain cancer has not spread to the brain stem.
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.
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