Could less radiation be safer for tough lung tumors?
NCT ID NCT04210492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a lower-dose radiation regimen for people with non-small cell lung cancer located near the center of the chest. The goal is to see if giving a total of 45 Gray in three sessions can control the tumor while reducing damage to nearby organs like the heart and major airways. The trial involves about 36 participants and tracks side effects and cancer control over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (45 Gray in 3 fractions)
- What this could lead to
- If successful, this approach could offer a safer radiation option for hard-to-treat central lung tumors, with fewer side effects and similar cancer control.
- What could go wrong
- This is an early-phase trial with only 36 participants, so results may not apply broadly. Lower radiation might be less effective at controlling tumors, and there are still risks of damage to nearby organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs. 2. ECOG Performance Status of 0-2 3. Age \> 18 4. Patients must sign a study-specific consent form. Exclusion Criteria: 1. Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in \<3Gy per fraction): * Spinal cord previously irradiated to \> 40 Gy * Brachial plexus previously irradiated to \> 50 Gy * Small intestine, large intestine, or stomach previously irradiated to \> 45Gy * Brainstem previously irradiated to \> 50 Gy * Lung previously irradiated with prior V20Gy \> 35% 2. Active systemic, pulmonary, or pericardial infection 3. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung 4. Pregnant or lactating 5. Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Smilow Cancer Hospital
RECRUITINGNew Haven, Connecticut, 06511, United States
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Smilow Cancer Hospital - Hamden Care Center
RECRUITINGHamden, Connecticut, 06518, United States
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Smilow Cancer Hospital Care Center - Guilford
RECRUITINGGuilford, Connecticut, 06437, United States
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Smilow Cancer Hospital Care Center - Trumbull
RECRUITINGTrumbull, Connecticut, 06611, United States
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Smilow Cancer Hospital Care Center - Waterford
RECRUITINGWaterford, Connecticut, 06385, United States
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Smilow Cancer Hospital Care Center at Greenwich
RECRUITINGGreenwich, Connecticut, 06830, United States
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