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Radiation Therapy
Stereotactic Radiosurgery for Brain Cancer
Phase 2
Recruiting
Led By Steven J. Chmura, M.D., Ph.D.
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more
Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing if not treating the margins around the tumor during radiation therapy will worsen progression free survival rates in patients with brain metastases.
Who is the study for?
This trial is for adults with certain types of cancer that has spread to the brain, showing 1-5 measurable lesions. Participants must understand and consent to the study, not be pregnant, have a reasonable life expectancy (3+ months), and good performance status. Excluded are those with specific cancers (like small cell carcinoma), brain stem metastases, recent chemotherapy or immunotherapy, prior cranial radiotherapy within 90 days or any previous stereotactic radiosurgery.Check my eligibility
What is being tested?
The study tests whether omitting treatment margins in stereotactic radiosurgery affects progression-free survival in patients with brain metastases. It's a randomized trial where participants will either receive standard treatment or an experimental approach without planning target volume margins.See study design
What are the potential side effects?
Stereotactic radiosurgery may cause headaches, nausea, fatigue, hair loss at the treatment site, swelling around the treated area leading to increased intracranial pressure or neurological symptoms depending on lesion location.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with the ability to care for myself and expected to live 3 months or more.
Select...
I have a brain tumor that is 3cm or smaller, and if there are more, they also do not exceed 3cm.
Select...
My cancer has spread to my brain, confirmed by a special MRI scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months
Secondary outcome measures
Association between dose and risk of radionecrosis or pseudoprogression
Local failure rates
Overall survival rates
+7 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%
Skin infection
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Sore throat
4%
Urinary tract infection
4%
Lethargy
4%
Infusion site extravasation
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Radiosurgery to 0 mm GTV to PTV marginsExperimental Treatment1 Intervention
Group II: Stereotactic Radiosurgery to 2 mm GTV to PTV marginsActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,611 Total Patients Enrolled
Steven J. Chmura, M.D., Ph.D.Principal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with leptomeningeal disease.I am an adult with the ability to care for myself and expected to live 3 months or more.My cancer has spread to critical areas of my brain or close to my optic nerves.I have not had brain radiation in the last 90 days or any specific radiation to lesions to be treated in this trial.I haven't had chemotherapy, targeted therapy, or immunotherapy within 14 days before SRS, except for hormonal therapy.I cannot have MRI scans with gadolinium due to a pacemaker, poor kidney function, or allergy.I have a brain tumor that is 3cm or smaller, and if there are more, they also do not exceed 3cm.I have been diagnosed with a germ cell tumor, small cell carcinoma, or a blood cancer.My cancer has spread to my brain, confirmed by a special MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Radiosurgery to 2 mm GTV to PTV margins
- Group 2: Stereotactic Radiosurgery to 0 mm GTV to PTV margins
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.
Has Stereotactic Radiosurgery been endorsed by the FDA?
"There is limited prior evidence attesting to the safety of Stereotactic Radiosurgery, so it was marked with a score of 2."
Answered by AI
Does this clinical experiment have any openings for volunteers?
"This trial, which was originally unveiled on June 10th 2016 and recently revised on June 29th 2021, is currently recruiting volunteers. The information can be found on clinicaltrials.gov."
Answered by AI
How many individuals can participate in this clinical research?
"Affirmative. As per the clinicaltrials.gov listing, this research endeavour is presently accepting participants with recruitment starting from June 10th 2016 and the most recent edit being on 29/6/2021. 166 patients must be found for enrolment at 1 medical centre."
Answered by AI
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