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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
Must not have
Diagnosis of leptomeningeal disease
Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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My cancer has spread to my brain, confirmed by a special MRI scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with leptomeningeal disease.
Select...
My cancer has spread to critical areas of my brain or close to my optic nerves.
Select...
I have not had brain radiation in the last 90 days or any specific radiation to lesions to be treated in this trial.
Select...
I cannot have MRI scans with gadolinium due to a pacemaker, poor kidney function, or allergy.
Select...
I have been diagnosed with a germ cell tumor, small cell carcinoma, or a blood cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
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

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
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,743 Total Patients Enrolled
Steven J. Chmura, M.D., Ph.D.Principal InvestigatorUniversity of Chicago

Media Library

Frameless Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02747303 — Phase 2
Brain Tumor Research Study Groups: Stereotactic Radiosurgery to 2 mm GTV to PTV margins, Stereotactic Radiosurgery to 0 mm GTV to PTV margins
Brain Tumor Clinical Trial 2023: Frameless Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT02747303 — Phase 2
Frameless Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02747303 — Phase 2
~24 spots leftby May 2026
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