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Radiation Therapy Techniques for Lung Cancer

N/A
Waitlist Available
Led By John Heinzerling, MD
Research Sponsored by Atrium Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status of ≤ 2
Stage IA-IIB (T1a-T3bN0) presumed non-small cell lung cancer, carcinoid tumors, or lung metastasis with ≥ 1 cm of respiratory associated motion on 4DCT
Must not have
Active ongoing pulmonary infection or pneumonitis requiring active treatment with antibiotics or steroids
Prior radiation to the chest overlapping with current radiation fields
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two different radiation therapy techniques for tumors in the lungs. One technique uses a guidance system to help target the radiation, and the other doesn't.

Who is the study for?
This trial is for adults over 18 with certain types of lung cancer or tumors that move when they breathe. They must be able to follow the study plan and use effective birth control if needed. People can't join if they've had chest radiation before, have an active lung infection or pneumonitis, or were treated for pneumonitis within the last 15 days.
What is being tested?
The study compares two ways to do SBRT (a type of radiation therapy) during breath holds for treating lung issues. One way uses SGRT with implanted markers called fiducials; the other just uses SGRT without these markers.
What are the potential side effects?
Potential side effects are not detailed in this summary but may include those typical of radiation therapy such as skin irritation, fatigue, shortness of breath, and inflammation of lung tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My lung tumor moves with my breath and is between 1-5 cm in size.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for a lung infection or inflammation.
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I have had radiation to the chest in the same area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of SBRT and fiducial-related pulmonary toxicities as assessed by NCI CTCAE v.5.0
Secondary study objectives
Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score
Local control of treated tumor(s)
Overall Survival
+1 more
Other study objectives
Incidence of Grade 2 or higher non-hematologic toxicities attributed to SBRT and fiducial implantation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
Breath hold SBRT with SGRT in combination with implanted fiducials
Group II: Group 2Experimental Treatment1 Intervention
Breath hold SBRT with SGRT
Group III: Group 1Experimental Treatment1 Intervention
Freebreathing SBRT with SGRT

Find a Location

Who is running the clinical trial?

Atrium Health Levine Cancer InstituteOTHER
26 Previous Clinical Trials
3,618 Total Patients Enrolled
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,888 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,991 Total Patients Enrolled

Media Library

Breath Hold SBRT Clinical Trial Eligibility Overview. Trial Name: NCT04060927 — N/A
Lung Cancer Research Study Groups: Group 1, Group 2, Group 3
Lung Cancer Clinical Trial 2023: Breath Hold SBRT Highlights & Side Effects. Trial Name: NCT04060927 — N/A
Breath Hold SBRT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04060927 — N/A
~6 spots leftby Oct 2025
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