4DCT-guided functional lung avoidance radiotherapy to spare high-function lung

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective single-arm study will enroll adults with lung malignancies scheduled for thoracic IMRT/VMAT or SBRT. All participants undergo 4DCT simulation to generate a ventilation map; the top 80% ventilation region is defined as the high-function lung and imported into the treatment planning system to create a functional lung avoidance radiotherapy (FLAR) plan. A conventional anatomic plan without functional guidance will also be created for paired, within-patient dosimetric comparison while maintaining PTV D95% and standard organ-at-risk constraints. The primary outcome is improved dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose), with secondary outcomes including incidence of radiation pneumonitis, radiation-induced lung injury, and overall treatment safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 85 years (inclusive); any sex.
* Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).
* Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT/VMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.
* Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.
* No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.
* Able to comply with treatment and follow-up assessments.
* Written informed consent provided.

Exclusion Criteria:

* Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
* Age \<18 or \>85 years.
* Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).
* Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.
* Concurrent other active/advanced malignancy requiring priority treatment that would confound study outcomes.
* Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.
* Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and/or scheduled follow-up.
* Inadequate 4DCT image quality or inability to generate/validate the 4DCT ventilation map required for functional-lung-guided planning.
* Any other condition deemed unsuitable by the investigators in the interest of participant safety.

Where it's running

• Cancer Center, Second Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting

Study contacts

• Principal investigator: zhengjun Guo, MD. — The Second Clinical College of Chongqing Medical University: The Second Affiliated Hospital of Chongqing Medical University
• Study coordinator: Zhi chen, MD.
• Email: 2023440076@stu.cqmu.edu.cn
• Phone: +86 18982928222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.