Study Summary
This trial is testing if higher doses of radiation can improve outcomes for people with brain metastases who have not had radiation before.
Eligible Conditions
- Brain Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 5 years
3 years
Local progression rate
Overall survival
Response rate
Time to progression
5 years
Health-related quality of life
Subgroup analysis
90 days
Maximal tolerated doses
Year 2
chronic toxicity
Trial Safety
Safety Progress
Side Effects for
Stereotactic Radiosurgery Followed by Erlotinib
32%Fatigue
28%Lymphocyte count decreased
24%Cough
20%Rash acneiform
20%Back pain
16%Dry skin
16%Rash maculo-papular
16%Anorexia
16%Hyperglycemia
12%Dyspepsia
12%Pain in extremity
12%Diarrhea
12%Aspartate aminotransferase increased
12%Headache
12%Nausea
12%Pain
12%Non-cardiac chest pain
8%Watering eyes
8%Blurred vision
8%Edema limbs
8%Abdominal pain
8%Paronychia
8%Arthralgia
8%Pruritus
8%Urinary tract pain
8%Skin and subcutaneous tissue disorders - Other, specify
8%Myalgia
8%Weight loss
8%Wheezing
4%Vomiting
4%Skin hyperpigmentation
4%Upper respiratory infection
4%Urinary tract infection
4%Fracture
4%Alkaline phosphatase increased
4%Hyperkalemia
4%Infusion site extravasation
4%Oral hemorrhage
4%Platelet count decreased
4%Bruising
4%Dysphagia
4%Conjunctivitis
4%Ear pain
4%Fall
4%Dry eye
4%Blood bilirubin increased
4%Edema face
4%Bone pain
4%Depression
4%Neck pain
4%Urinary urgency
4%Skin infection
4%Gastroesophageal reflux disease
4%Lethargy
4%Dysgeusia
4%Epistaxis
4%Flu like symptoms
4%Hypernatremia
4%Nail loss
4%Nail ridging
4%Flashing lights
4%Insomnia
4%Hot flashes
4%Neutrophil count decreased
4%Sore throat
4%Papulopustular rash
4%White blood cell decreased
4%Pneumonitis
Trial Design
1 Treatment Group
Stereotactic Radiosurgery
1 of 1
Experimental Treatment
135 Total Participants · 1 Treatment Group
Primary Treatment: Stereotactic Radiosurgery · No Placebo Group · N/A
Stereotactic Radiosurgery
Radiation
Experimental Group · 1 Intervention: Stereotactic Radiosurgery · Intervention Types: RadiationTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2010
Completed Phase 2
~360
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
962 Previous Clinical Trials
1,108,352 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.
Eligibility Criteria
Age 18+ · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Any cancer that has spread to the brain must not be located in the brain stem.
You are able to perform daily activities without assistance, and your overall health status is fair or better.