RecruitingNCT07441941

Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup

Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

190 participants

Start Date

Jan 14, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Pulmonary tumors, whether primary or metastatic, represent a major challenge in oncology. Primary lung cancers are responsible for nearly 37,000 deaths per year in France, highlighting the critical importance of their management. Moreover, secondary pulmonary lesions are present in 20% of solid cancers and show wide variability in prognosis. Oligometastatic disease (≤ 3 to 5 lesions) is associated with a better prognosis, justifying the development of local treatments for these lesions, particularly stereotactic radiotherapy. During the COVID-19 pandemic, single-fraction protocols (30-34 Gy) were implemented to limit patient exposure, showing outcomes equivalent to multi-fraction regimens for both primary and secondary lesions. However, the impact of these treatments on quality of life remains poorly documented-especially for non-small cell lung carcinoma-and needs to be further explored to optimize their integration into routine clinical practice. The primary objective of this study is to assess the impact of single-fraction stereotactic body radiotherapy (SBRT) for pulmonary lesions on quality of life. To this end, patients will complete a standardized French-language quality of life questionnaire, the EORTC QLQ-C30 and LC-29, before treatment and at 1 month (M1), 3 months (M3), 6 months (M6), 9 months (M9), and 12 months (M12) after treatment. This validated, disease-specific questionnaire comprises 59 items: 30 assessing overall quality of life (QLQ-C30) and 29 addressing aspects related to lung cancer treatments (LC-29). It includes questions on respiratory symptoms, chest pain, fatigue, and the functional impact of the treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes and quality of life for people with early-stage or limited lung tumors who receive a single high-dose radiation treatment (called single-fraction stereotactic body radiotherapy, or SBRT). This approach delivers focused radiation in one session rather than many smaller doses over weeks. **You may be eligible if...** - You are 18 or older - You have a small (3 cm or less), early-stage non-small cell lung cancer (NSCLC) with no spread to lymph nodes or other organs, OR you have a small number of lung metastases (3 or fewer) from another cancer - Your tumor cannot be surgically removed, or you have chosen not to have surgery - Your tumor is in the outer part of the lung, away from the main airways - Your general health is acceptable (ECOG 0–2) - You are covered by French health insurance **You may NOT be eligible if...** - Your tumor is invading the lung lining or the middle of the chest (mediastinum) - You currently have a lung infection or pericarditis - You have had prior radiation to the same area - You are currently receiving pre-surgery treatment for this cancer - You are pregnant or breastfeeding - Your life expectancy is less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Montpellier Cancer Institut

Montpellier, ICM, France

Lorraine Cancer Institute

Vandœuvre-lès-Nancy, France

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NCT07441941


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