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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
Study 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.Check my eligibility
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.See study design
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 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
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 outcome measures
Local control
Overall survival (OS)
Other outcome measures
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 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%
White blood cell decreased
4%
Lethargy
4%
Infusion site extravasation
4%
Skin infection
4%
Sore throat
4%
Upper respiratory infection
4%
Urinary tract infection
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: RadiationExperimental Treatment1 Intervention
Stereotactic Radiosurgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~490
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,052 Previous Clinical Trials
1,054,895 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received radiation treatment to your entire brain in the past.You have cancer that has spread to the tissues surrounding the brain and spinal cord.You are not expected to live for more than 4 months.The biggest tumor is no larger than 4 centimeters.You have not received a specific type of radiation treatment to the areas that will be treated in this study.You are able to perform daily activities without help or only need a little help.You have been diagnosed with a type of cancer that is not related to blood cells, except for germ cell cancer. If you have small cell lung cancer, you can participate in this study.You have six or more spread out cancer spots in your body, including in your brain.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation
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.
What specific objectives is this trial attempting to accomplish?
"This 4-month clinical trial seeks to evaluate the toxicity level, local control rate, and overall survival of patients with 6 or more intracranial metastases. Secondary outcomes include ascertaining the most efficacious dose for local control as well as determining overall survival from date of SRS (Stereotactic Radiosurgery) to date of death."
Answered by AI
Is there currently a recruitment process underway for this clinical trial?
"Affirmative. Clinicaltrials.gov's repository of research data reveals that this medical trial, initially posted on December 5th 2017, is actively recruiting individuals for participation. 80 patients need to be recruited from a single location."
Answered by AI
How many people can potentially participate in this research experiment?
"Affirmative. Data on clinicaltrials.gov reveals that this research endeavour, which was first posted on December 5th 2017, is actively recruiting participants. A total of 80 trial volunteers need to be sourced from 1 site."
Answered by AI
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