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Radiation Therapy Techniques for Lung Cancer
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My lung tumor moves with my breath and is between 1-5 cm in size.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approx. 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of SBRT and fiducial-related pulmonary toxicities as assessed by NCI CTCAE v.5.0
Secondary outcome measures
Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score
Local control of treated tumor(s)
Overall Survival
+1 moreOther outcome measures
Incidence of Grade 2 or higher non-hematologic toxicities attributed to SBRT and fiducial implantation
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
17 Previous Clinical Trials
1,475 Total Patients Enrolled
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,809 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,162 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on chemotherapy or other treatments but can stop them for SBRT.My tumor is 7 cm or smaller, confirmed or suspected to be cancer.I can take care of myself but might not be able to do heavy physical work.I can follow the study's procedures for its duration.I am currently being treated for a lung infection or inflammation.I have had radiation to the chest in the same area before.My lung tumor moves with my breath and is between 1-5 cm in size.I agree to use birth control if I can have children or am with someone who can.I was treated for lung inflammation from a drug or therapy within the last 15 days.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
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.
How many individuals have consented to take part in this experiment?
"Absolutely. Per the data posted on clinicaltrials.gov, this research is actively recruiting participants as of November 21st 2022; the trial was first made available for recruitment in August 30th 2019 and requires 45 patients from a single medical site."
Answered by AI
Are volunteers still being sought for this experiment?
"Clinicaltrials.gov confirms that this medical trial is actively seeking new participants, with the first posting on August 30th 2019 and last update occurring just recently on November 21st 2022."
Answered by AI
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