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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years post-enrollment.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years post-enrollment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of the stereotactic body radiotherapy regimen (SBRT)

local control (LC) of 3-fraction stereotactic body radiotherapy

Secondary outcome measures

distant control

lobar control

overall survival

+2 more

Other outcome measures

organ at risk (OAR) dosimetry

quality of life (QOL)

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,330 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

Non-Small Cell Lung Cancer Research Study Groups: 45 Gy

Non-Small Cell 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current recruitment rate for this experiment?

"Affirmative. From clinicaltrials.gov, we can ascertain that this research endeavour was initially posted on March 2nd 2020 and is still actively seeking enrolment from 60 participants at a single site."

Answered by AI

Is this experiment still seeking participants?

"Per the clinicaltrials.gov website, this experiment is actively amassing participants. It was first put up on March 2nd 2020 and last altered on July 20th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

2020. "Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210492.

All > Lung Cancer New York