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Radiation Therapy
Stereotactic Radiation for Lung Cancer with Brain Metastases
N/A
Waitlist Available
Led By Ayal A Aizer, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases
Age >=18 years at diagnosis of brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death or loss to follow up, up to 24 months
Awards & highlights
Study Summary
This trial is comparing:
Who is the study for?
This trial is for adults with small cell lung cancer who have 1-10 brain metastases visible on MRI. It's open to those who've had previous systemic therapy and possibly surgery for brain metastases, but not to those who've had prior brain radiation, can't receive gadolinium, have widespread leptomeningeal disease, more than six brain lesions, received preventive cranial radiation, severe kidney disease or inadequate mental capacity.Check my eligibility
What is being tested?
The study tests stereotactic radiation—a precise type of radiation that targets individual tumors without affecting the surrounding brain—against traditional whole-brain radiation in treating patients with small cell lung cancer that has spread to the brain.See study design
What are the potential side effects?
Stereotactic radiation may cause headaches, fatigue, hair loss at treatment site, skin irritation around the targeted area and temporary swelling or more serious side effects like changes in cognitive function depending on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My small cell lung cancer has spread to my brain.
Select...
I was 18 or older when my brain cancer was diagnosed.
Select...
I had surgery to remove brain metastases but haven't started follow-up radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until death or loss to follow up, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or loss to follow up, up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Death due to progressive neurologic disease
Secondary outcome measures
Ability to complete activities of daily living
Perinatal death
Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course
+13 moreSide effects data
From 2019 Phase 1 & 2 trial • 160 Patients • NCT0205264867%
Hypotension
67%
Nausea
67%
Constipation
67%
Cough
33%
Vision blurred
33%
Dyspnoea
33%
Seizure
33%
Fatigue
33%
Traumatic haematoma
33%
Mood altered
33%
Abdominal pain
33%
Pain in extremity
33%
Hyperchloraemia
33%
Urinary incontinence
33%
Micturition urgency
33%
Pollakiuria
33%
Nocturia
33%
Pain
33%
Rectal haemorrhage
33%
Hypokalaemia
33%
Proctitis
33%
Sepsis
33%
Haemorrhoids
33%
Hyperglycaemia
33%
Decreased appetite
33%
Vomiting
33%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Dose Level 1
Phase 2 Cohort 2b
Phase 2 Cohort 2a
Phase 1 Dose Level 2
Phase 1 Dose Level 3
Phase 2 Cohort 2c
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic RadiationExperimental Treatment1 Intervention
Stereotactic radiation will begin within 14 days of the MRI used for radiation planning
Lesions <2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction
Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction
Lesions >3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiation
2014
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
341,133 Total Patients Enrolled
Ayal A Aizer, MDPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive gadolinium.My small cell lung cancer has spread to my brain.I have had treatment that affects my whole body.My kidney function is severely reduced or I am on dialysis.My cancer has spread to the lining of my brain and spinal cord.I have more than 6 confirmed brain tumors.I am unable to complete questionnaires due to mental capacity.You must have between 1 and 10 clearly visible brain lesions on an MRI scan.I was 18 or older when my brain cancer was diagnosed.I have had radiation to my head to prevent cancer spread to the brain.I had surgery to remove brain metastases but haven't started follow-up radiation.I have had radiation treatment for brain cancer spread.My tumor is larger than 5 cm and has not been removed.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Radiation
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.
Are recruitment procedures currently underway for this research endeavor?
"Affirmative. According to clinicaltrials.gov, the trial first listed in February of 2018 is currently recruiting patients. Updates were made most recently on July 18th 2022 and a total of 100 volunteers will be enrolled from 1 medical facility."
Answered by AI
How many individuals have enrolled in this experiment?
"Correct. Clinicaltrial.gov data shows that this experiment is currently accepting participants, having been initially posted on February 23rd 2018 and most recently updated July 18th 2022. A hundred subjects are sought from a single location to partake in the trial."
Answered by AI
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