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Could less radiation be safer for tough lung tumors?

NCT ID NCT04210492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Smilow Cancer Hospital

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Smilow Cancer Hospital - Hamden Care Center

    RECRUITING

    Hamden, Connecticut, 06518, United States

  • Smilow Cancer Hospital Care Center - Guilford

    RECRUITING

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center - Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital Care Center - Waterford

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital Care Center at Greenwich

    RECRUITING

    Greenwich, Connecticut, 06830, United States

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