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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
Must not have
Subjects must not be pregnant or nursing at the time of SRS treatment due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Patients with leptomeningeal metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have 10 or fewer brain tumors.
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My cancer is not related to blood, small cell lung, germ cell, or an unknown primary.
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I can care for myself but cannot do regular physical activities without help.
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I am 18 years old or older.
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My largest cancer lesion is 3.0 cm or smaller.
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My brain cancer has not spread to the brain stem.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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My cancer has spread to the lining of my brain and spinal cord.

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
Maximal tolerated doses
Secondary study objectives
Local progression rate
Overall survival
Response rate
+1 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%
Urinary tract pain
8%
Watering eyes
8%
Weight loss
8%
Myalgia
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%
Upper respiratory infection
4%
Vomiting
4%
Urinary tract infection
4%
White blood cell decreased
4%
Lethargy
4%
Sore throat
4%
Skin infection
4%
Urinary urgency
4%
Insomnia
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: Stereotactic RadiosurgeryExperimental Treatment1 Intervention
Radiation, Stereotactic Radiosurgery Dose-Escalation
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
1,089 Previous Clinical Trials
1,059,548 Total Patients Enrolled
Robert Timmerman, MD4.25 ReviewsPrincipal Investigator - UTSW
University of Texas Southwestern Medical Center
5 Previous Clinical Trials
10,338 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

Stereotactic Radiosurgery (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT02645487 — N/A
Brain Cancer Research Study Groups: Stereotactic Radiosurgery
Brain Cancer Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT02645487 — N/A
Stereotactic Radiosurgery (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02645487 — N/A
~24 spots leftby Dec 2026
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