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Radiation Therapy
CT-Guided Stereotactic Radiotherapy for Lung Cancer
N/A
Recruiting
Led By Pamela Samson, M.D., MPHS
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer or mediastinal recurrent non-small cell lung cancer with plans to be treated with definitive intent SBRT alone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-completion of treatment (estimated to be 12 months and 5 days)
Awards & highlights
Study Summary
This trial will look at the safety of a new type of radiation therapy to treat early-stage lung cancer, aiming to reduce serious side effects.
Who is the study for?
This trial is for adults with early-stage non-small cell lung cancer that's inoperable or surgery-refused, and located centrally or ultra-centrally. Participants need good bone marrow function, the ability to hold their breath for 10 seconds, a specific performance status score, and no history of radiotherapy where SBRT will be applied. Pregnant or breastfeeding individuals are excluded.Check my eligibility
What is being tested?
The study tests CT-guided stereotactic adaptive radiotherapy (CT-STAR) using ETHOS technology on patients with central/ultra-central lung cancers. It aims to reduce severe toxicity by adapting daily treatment plans to protect surrounding organs while delivering a potent short course of radiation.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include skin reactions at the treatment site, fatigue, inflammation of lung tissue leading to coughing or difficulty breathing, and other organ-specific issues due to high-dose radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My lung cancer is in the early stages or has returned in the chest area, and I plan to undergo targeted radiation therapy.
Select...
My cancer lesions are in the central part of my lung.
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My condition cannot be treated with surgery or I have chosen not to undergo surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-completion of treatment (estimated to be 12 months and 5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-completion of treatment (estimated to be 12 months and 5 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of grade 3 or greater toxicity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR)Experimental Treatment2 Interventions
In this study, consenting and eligible patients will receive a prescription dose of 55 Gy in 5 fractions delivered on consecutive business days with adaptation based on daily anatomic changes as per clinical standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ETHOS
2021
N/A
~10
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,678 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,762 Total Patients Enrolled
Pamela Samson, M.D., MPHSPrincipal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious, ongoing health problem.Your CT scan shows that the lesions have spread into the walls of the airways or major blood vessels.My doctor says I'm fit for targeted radiation therapy.I am 18 years old or older.My lung cancer is in the early stages or has returned in the chest area, and I plan to undergo targeted radiation therapy.My doctors agree my tumor can be effectively targeted in treatment planning.I have had cancer before, but it won't affect this study's results.My cancer lesions are in the central part of my lung.I can hold my breath for at least 10 seconds.I have had radiation in the same area where SBRT is planned.I've been mostly active and able to care for myself in the last month.My blood tests from the last 30 days show my bone marrow works well.I have an active diagnosis of cancer that has spread to other parts of my body.My condition cannot be treated with surgery or I have chosen not to undergo surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR)
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.
Are there currently any opportunities to join this research endeavor?
"This clinical trial, whose most recent edit was on March 14th 2023, is not presently enrolling patients. However, there are 1,959 other studies that have open recruitment slots according to the information provided by clinicialtrials.gov."
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