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Radiation

Stereotactic Radiosurgery for Lung Cancer with Brain Metastases

Memorial Sloan Kettering Nassau, Rockville Centre, NY
Targeting 6 different conditionsStereotactic Radiosurgery +1 morePhase 2RecruitingLed by Luke Pike, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

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.

Eligible Conditions
  • Lung Cancer
  • Brain Metastases
  • Brain Tumor
  • Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with small cell lung cancer.
Select...
You have been diagnosed with up to 10 brain tumors using a special type of MRI scan.
Select...
You are able to perform daily activities with little to no difficulty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 • 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%
Watering eyes
8%
Weight loss
8%
Wheezing
8%
Urinary tract pain
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Myalgia
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Urinary tract infection
4%
Sore throat
4%
Vomiting
4%
Urinary urgency
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Skin infection
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%
Infusion site extravasation
4%
Insomnia
4%
Lethargy
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: 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
1,911 Previous Clinical Trials
588,880 Total Patients Enrolled
Luke Pike, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Stereotactic Radiosurgery (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05419076 — Phase 2
Lung Cancer Research Study Groups: Participants with small cell lung cancer with brain metastases
Lung Cancer Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT05419076 — Phase 2
Stereotactic Radiosurgery (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419076 — Phase 2

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 Yorkg 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?

Most responsive sites:
  1. Memorial Sloan Kettering Bergen: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
2022. "A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419076.
All > Brain Metastases > Sclc
~31 spots leftby Jun 2025
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