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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

Patients who have undergone prior systemic therapy are eligible

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 below

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My small cell lung cancer has spread to my brain.

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I have had treatment that affects my whole body.

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I was 18 or older when my brain cancer was diagnosed.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and until death or loss to follow up, up to 24 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

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 more

Side effects data

From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648

67%

Hypotension

67%

Nausea

67%

Constipation

67%

Cough

33%

Pain in extremity

33%

Vision blurred

33%

Pollakiuria

33%

Nocturia

33%

Seizure

33%

Fatigue

33%

Traumatic haematoma

33%

Mood altered

33%

Abdominal pain

33%

Micturition urgency

33%

Hyperchloraemia

33%

Urinary incontinence

33%

Pain

33%

Rectal haemorrhage

33%

Hypokalaemia

33%

Haemorrhoids

33%

Hyperglycaemia

33%

Decreased appetite

33%

Vomiting

33%

Proctitis

33%

Dyspnoea

33%

Sepsis

33%

Pyrexia

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,772 Total Patients Enrolled

Ayal A Aizer, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Stereotactic Radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03391362 — N/A

Small Cell Lung Cancer Research Study Groups: Stereotactic Radiation

Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Radiation Highlights & Side Effects. Trial Name: NCT03391362 — N/A

Stereotactic Radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03391362 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases

Ayal Aizer, MD 2018. "Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03391362.

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