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Radiation Therapy

Low-Dose SBRT for Lung Cancer

Phase 1 & 2
Recruiting
Led By Henry S. Park, MD, MPH
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status of 0-2
Lung tumors will be ≤ 5 cm and centrally located, as per specific definitions
Must not have
Prior history of radiotherapy near target lesion resulting in overlapping treatment fields
No active systemic, pulmonary, or pericardial infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years post-enrollment.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a lower-dose SBRT regimen for tumors in the chest.

Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer that's centrally located and no larger than 5 cm. They should be relatively fit (ECOG 0-2), able to consent, not pregnant or breastfeeding, free of serious infections, significant heart disease, prior radiotherapy in the area, or lung fibrosis.
What is being tested?
The study is testing a reduced dose of stereotactic body radiotherapy (SBRT) at 45 Gray delivered in three sessions for treating central lung tumors. The goal is to see if lower doses are effective and possibly lead to fewer side effects.
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, shortness of breath due to inflammation or damage to surrounding lung tissue, chest pain from irritation of nearby structures and possible risks associated with radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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My lung tumor is 5 cm or smaller and located in the center of my lung.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had radiation before on the same area where my current cancer is.
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I do not have any ongoing infections.
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I do not have serious heart problems.
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I do not have lung fibrosis or pneumonia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post-enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years post-enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of the stereotactic body radiotherapy regimen (SBRT)
local control (LC) of 3-fraction stereotactic body radiotherapy
Secondary study objectives
lobar control
regional control
Other study objectives
quality of life (QOL)

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: 45 GyExperimental Treatment1 Intervention
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,438 Total Patients Enrolled
Henry S. Park, MD, MPHPrincipal InvestigatorYale University

Media Library

45 Gray (Gy) regimen (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04210492 — Phase 1 & 2
Lung Cancer Research Study Groups: 45 Gy
Lung Cancer Clinical Trial 2023: 45 Gray (Gy) regimen Highlights & Side Effects. Trial Name: NCT04210492 — Phase 1 & 2
45 Gray (Gy) regimen (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04210492 — Phase 1 & 2
~18 spots leftby Jan 2030
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