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Can shrinking radiation margins spare lungs without sacrificing cancer control?

NCT ID NCT06542159

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether using real-time adaptive radiation without the usual safety margin can reduce lung side effects in people with early-stage non-small cell lung cancer or limited lung metastases. About 130 participants will be randomly assigned to either standard radiation or the new adaptive technique. The main goal is to see if the new method lowers the chance of breathing problems while still controlling the cancer.

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 (online adaptive stereotactic body radiotherapy without PTV expansion margin)
What this could lead to
If successful, this approach could reduce breathing-related side effects from radiation while still effectively controlling early-stage lung cancer or limited lung metastases.
What could go wrong
This is a phase II trial with only 130 participants, so results are preliminary. Removing safety margins might increase the risk of missing the tumor, and the technique requires specialized equipment not widely available.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

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

Started

May 2024

Expected to finish

Apr 2028

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: * Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT/chest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm). * Age 18 years or older, regardless of gender. * ECOG performance status score of 0-2. * Serum hemoglobin ≥ 80 g/L, platelets ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL. * Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml/min. * Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL. * FEV1 ≥ 0.5 L. * Normal CB6 range. * The patient and their family agree and sign the informed consent form. Exclusion Criteria: * Tumors with bronchial invasion are excluded. * Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias). * Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals. * Individuals with substance abuse issues, chronic alcoholism, or AIDS. * Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders. * Individuals with a history of severe allergies or specific sensitivities.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adaptive radiotherapy Lung oligometastases Non-small cell lung cancer Stereotactic body radiotherapy Toxicity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Sun yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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