← Back to Search

Radiation Therapy

Radiosurgery for Brain Metastases

Phase 1 & 2
Recruiting
Led By Zabi Wardak, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is to find the best dose of a new drug to treat Alzheimer's, and to see if it can help with cognitive decline.

Who is the study for?
This trial is for adults over 18 with non-blood related cancers, like small cell lung carcinoma, who have six or more brain metastases but no larger than 4 cm. They should be relatively active (able to care for themselves) and not pregnant. They must agree to use birth control during the study. People with prior whole-brain radiation, leptomeningeal metastasis, a life expectancy under four months, or certain psychiatric conditions can't join.
What is being tested?
The trial is testing Stereotactic Radiosurgery (SRS), a precise form of radiation therapy aimed at brain tumors. The first phase determines the highest dose patients can take without serious side effects; the second phase looks at how this treatment affects patients' thinking and memory skills over time.
What are the potential side effects?
While specific side effects are not listed here, SRS commonly includes risks such as headaches, fatigue, swelling around the treated area which may affect neurological functions depending on tumor location and doses received.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Phase I: To determine the toxicity within 60 days from the date of SRS, in patients with a greater intracranial disease burden, defined as 6 or more metastases.
Phase II: Determine the cognitive deterioration (HVLT delayed recall) in patients treated with SRS for multiple metastases (from baseline to 4 months)
Secondary study objectives
Local control
Overall survival (OS)
Other study objectives
Prospectively collect and analyze hippocampal dose and relation to neurocognitive decline
Prospectively collect and analyze histology and mutational/hormone status. This is an exploratory outcome and was added as a in error.
Prospectively collect and analyze neurologic symptoms at the time of SRS
+13 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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RadiationExperimental Treatment1 Intervention
Stereotactic Radiosurgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,109 Total Patients Enrolled
Zabi Wardak, MD5.02 ReviewsPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
5Patient Review
Dr. Wardak is excellent. He's been treating my brain cancer for the last four years, and I really appreciate how he takes the time to explain things to me in detail. He's also very caring — he's called me just to check in and see how I'm doing on more than one occasion. I really trust him and feel like he has my best interests at heart.

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03508752 — Phase 1 & 2
Brain Tumor Research Study Groups: Radiation
Brain Tumor Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT03508752 — Phase 1 & 2
Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03508752 — Phase 1 & 2
~3 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top