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Radiation
Stereotactic Radiosurgery for Brain Metastases from Lung Cancer
Phase 2
Recruiting
Led By Luke Pike, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment
Radiographic diagnosis of up to 10 brain metastases on contrast-enhanced MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether stereotactic radiosurgery/SRS is an effective treatment for people newly diagnosed with brain metastases from small cell lung cancer/SCLC.
Who is the study for?
This trial is for adults with small cell lung cancer that has spread to the brain. They must be able to consent, have a good performance status (able to carry out daily activities), and women must not be pregnant. People can't join if they've had previous brain radiotherapy, are pregnant or breastfeeding, can't undergo MRI scans, or have uncontrolled systemic disease.Check my eligibility
What is being tested?
The study is testing Stereotactic Radiosurgery (SRS) as a treatment for patients with newly diagnosed brain metastases from small cell lung cancer. It will involve precise delivery of radiation to the brain tumors without affecting surrounding healthy tissue.See study design
What are the potential side effects?
Potential side effects of SRS may include headaches, fatigue, nausea, hair loss at the treatment site, swelling in the brain which might cause neurological symptoms like weakness or difficulty speaking.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not able to become pregnant or I have a negative pregnancy test.
Select...
I have up to 10 brain tumors identified by MRI.
Select...
I am 18 years old or older.
Select...
I can care for myself and perform daily activities.
Select...
My diagnosis is small cell lung cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
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%
Wheezing
8%
Watering eyes
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%
Upper respiratory infection
4%
White blood cell decreased
4%
Sore throat
4%
Urinary tract infection
4%
Skin 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
1Treatment groups
Experimental Treatment
Group I: Participants with small cell lung cancer with brain metastasesExperimental Treatment2 Interventions
Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cerebrospinal fluid collection
2015
N/A
~220
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,560 Total Patients Enrolled
Luke Pike, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI with a special dye to show clearer pictures of your brain or spine.I have a severe illness with no treatment options, confirmed by scans within the last 3 months.I am not able to become pregnant or I have a negative pregnancy test.I have up to 10 brain tumors identified by MRI.I am 18 years old or older.I have had radiation therapy targeted at my brain.I can care for myself and perform daily activities.My cancer has spread to the lining of my brain or spinal cord.My diagnosis is small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with small cell lung cancer with brain metastases
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 there an active recruitment process for this trial?
"This clinical trial, which was initially advertised on June 10th 2022 according to clinicialtrials.gov is actively recruiting participants. The post has been amended most recently on November 11th 2022."
Answered by AI
Has Stereotactic Radiosurgery been accepted and certified by the Food and Drug Administration?
"Preliminary evidence suggests that Stereotactic Radiosurgery is safe, granting it a rating of 2. Nevertheless, this Phase 2 trial has yet to provide data supporting the efficacy of such treatments."
Answered by AI
What is the size of the sample population for this experiment?
"Affirmative. According to clinicaltrials.gov, this medical study is still in search of suitable candidates after being initially posted on June 10th 2022 and last edited November 11th 2022. At present, it requires 62 patients across 7 sites."
Answered by AI
How many sites are responsible for administering this experiment?
"Currently, seven medical centres are actively recruiting patients. A few of these include Memorial Sloan Kettering Suffolk - Commack in Commack, Memorial Sloan Kettering Cancer Center (All Protocol Activities) in New york, and the Memorial Sloan Kettering Bergen site in Montvale."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
How old are they?
18 - 65
What site did they apply to?
Memorial Sloan Kettering Bergen
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Most responsive sites:
- Memorial Sloan Kettering Bergen: < 24 hours
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