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Radiation Therapy
Stereotactic Radiosurgery for Brain Cancer
Phase 1
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically confirmed brain metastases by CT or MRI criteria
Patients must have 1-5 untreated brain metastases total
Must not have
Primary lesion with radiosensitive histology that includes small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma
Women of child-bearing potential who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum tolerated dose of stereotactic radiosurgery will be evaluated throughout the treatment period which is expected to last 12 weeks per patient
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how much radiation patients with brain metastases can tolerate when receiving stereotactic radiosurgery.
Who is the study for?
This trial is for adults with 1-5 untreated brain metastases, each no larger than 40 mm. They must have a performance status indicating they can care for themselves and agree to use birth control during and after the study. People who've had prior brain radiation or whose tumors are in sensitive areas like the optic nerve or brain stem cannot join.
What is being tested?
The trial tests increasing doses of stereotactic radiosurgery (a precise form of radiation therapy) to find the highest dose patients with new brain metastases can tolerate without severe side effects.
What are the potential side effects?
Potential side effects include headaches, nausea, fatigue, hair loss at treatment site, swelling around the tumor which might cause neurological issues depending on location, and very rarely radiation necrosis where treated tissue dies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain scans show cancer spread.
Select...
I have between 1 and 5 brain tumors that have not been treated.
Select...
My tumor is 20 mm or smaller, as measured by CT or MRI.
Select...
My tumor is between 10 mm and 20 mm in size.
Select...
My tumor is 40 mm or smaller, as measured by CT or MRI.
Select...
I am 18 years old or older.
Select...
I can care for myself but may need occasional help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer type is known to respond well to radiation therapy.
Select...
I am pregnant or breastfeeding.
Select...
I have had radiation therapy to my brain.
Select...
I have a brain lesion larger than 40 mm.
Select...
My cancer is in a place where focused radiation can't be used.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
My brain tumor is in the brain stem.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ maximum tolerated dose of stereotactic radiosurgery will be evaluated throughout the treatment period which is expected to last 12 weeks per patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maximum tolerated dose of stereotactic radiosurgery will be evaluated throughout the treatment period which is expected to last 12 weeks per patient
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose of stereotactic radiosurgery
Side 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%
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: Stereotactic RadiosurgeryExperimental Treatment1 Intervention
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 UtahLead Sponsor
1,139 Previous Clinical Trials
1,697,310 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father a child and agree to use birth control during and for 3 months after radiation.I have multiple tumors that fit a full study group, and the study's early safety period isn't over.My cancer type is known to respond well to radiation therapy.I am pregnant or breastfeeding.My brain scans show cancer spread.I've had brain surgery, but my current brain lesion isn't in the same area.I have between 1 and 5 brain tumors that have not been treated.My tumor is 20 mm or smaller, as measured by CT or MRI.I have up to five small brain tumors (≤10mm) eligible for treatment in the trial.My tumor is between 10 mm and 20 mm in size.My tumor is 40 mm or smaller, as measured by CT or MRI.I have stopped any BRAF inhibitor treatments at least 7 days ago.I am 18 years old or older.I can care for myself but may need occasional help.I can make my own medical decisions and have signed the consent form.I have had radiation therapy to my brain.I have a brain lesion larger than 40 mm.My cancer is in a place where focused radiation can't be used.My cancer has spread to the lining of my brain and spinal cord.My brain tumor is in 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.
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