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Radiation Therapy

Stereotactic Radiosurgery for Brain Cancer (NASRS Trial)

N/A
Recruiting
Led By David Shultz, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresected lesions or lesions with no planned immediate resection must measure < 3.0 cm on contrasted MRI or CT brain scan obtained ≤ 35 days prior to pre-registration
ECOG ≤ 2
Must not have
Metastatic germ cell tumor, small cell carcinoma, lymphoma, or any primary brain tumor
Prior cranial radiotherapy targeting the index lesion or any prior WBRT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with 1-6 brain metastases who will receive neo-adjuvant stereotactic radiosurgery.

Who is the study for?
This trial is for patients with 1-6 brain metastases, where at least one tumor is large enough to consider surgery but hasn't been operated on yet. Participants must be able to undergo stereotactic radiosurgery (SRS), have a good performance status (ECOG ≤2), and not be pregnant or have certain conditions like widespread cancer in the spinal fluid or previous treatments that would exclude them.
What is being tested?
The study tests neoadjuvant stereotactic radiosurgery (NASRS) on patients with large brain tumors before any surgical intervention. It's a phase II trial focusing on those who haven't had their tumors removed yet and can tolerate this precise form of radiation therapy aimed at shrinking the tumors.
What are the potential side effects?
While specific side effects are not listed, SRS may cause headaches, swelling, fatigue, hair loss at treatment site, nausea, and short-term memory issues. Long-term risks include radiation necrosis which can lead to neurological deficits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain scan shows lesions smaller than 3.0 cm, and I have no immediate surgery planned.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My MRI shows 1-6 cancer spots, with the largest no bigger than 3.0 cm.
Select...
My cancer is not lymphoma, small cell carcinoma, or seminoma.
Select...
My lesion is between 2 and 4 cm, hasn't had SRS, and needs to be removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is a type of metastatic germ cell tumor, small cell carcinoma, lymphoma, or brain tumor.
Select...
I have had brain radiation for my current cancer.
Select...
My treatment plan cannot avoid harming healthy tissues.
Select...
I haven't had chemotherapy in the last 7 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Radiation toxicity
Secondary study objectives
Survival
leptomeningeal disease
local control

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%
Weight loss
8%
Watering eyes
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: Arm 1Experimental Treatment1 Intervention
Neoadjuvant SRS
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 Health Network, TorontoLead Sponsor
1,526 Previous Clinical Trials
503,216 Total Patients Enrolled
David Shultz, MDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Neoadjuvant Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03368625 — N/A
Brain Tumor Research Study Groups: Arm 1
Brain Tumor Clinical Trial 2023: Neoadjuvant Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT03368625 — N/A
Neoadjuvant Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03368625 — N/A
~4 spots leftby Dec 2025
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