Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
NASRS Trial 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.Check my eligibility
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.See study design
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.
NASRS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
NASRS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiation toxicity
Secondary outcome measures
Survival
leptomeningeal disease
local control
+2 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
NASRS 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
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,060 Total Patients Enrolled
David Shultz, MDPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of metastatic germ cell tumor, small cell carcinoma, lymphoma, or brain tumor.My brain scan shows lesions smaller than 3.0 cm, and I have no immediate surgery planned.I can take care of myself and am up and about more than half of my waking hours.My MRI shows 1-6 cancer spots, with the largest no bigger than 3.0 cm.My cancer is not lymphoma, small cell carcinoma, or seminoma.My lesion is between 2 and 4 cm, hasn't had SRS, and needs to be removed.A specialist has approved me for a specific brain treatment.I have had brain radiation for my current cancer.My treatment plan cannot avoid harming healthy tissues.I haven't had chemotherapy in the last 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
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.
Is this trial currently recruiting participants?
"Clinicaltrials.gov attests that recruitment is still ongoing for this study, which was initially posted on March 19th 2018 and most recently updated on April 14th 2022."
Answered by AI
What is the maximum number of individuals being enrolled in this medical experiment?
"Affirmative. Data available on clinicaltrials.gov demonstrates that this research, which was initially advertised on March 19th 2018 is currently recruiting participants. Up to 30 people are needed from a single medical center for the study's completion."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger