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

Recruitingn/aAges 18 Years - anyAllInstitut du Cancer de Montpellier - Val d'Aurelle
NCT07441941 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 explo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age: ≥ 18 years * Patient receiving single-fraction stereotactic body radiation therapy (SBRT) * Stage T1-2 N0 M0 non-small cell lung cancer (NSCLC) (AJCC 6th edition) or oligometastatic lung tumor defined by ≤ 3 lung metastasis. * Inoperability: Tumor is inoperable or patient refuses surgery * Tumor size: ≤ 3 cm * Peripheral tumors: \> 2 cm from proximal bronchial tree but ≥ 0.5 cm from the wall * Histologically proven or with evolution criteria (CT scan and PET scan) * ECOG performance status: 0-2 * Ability to comply: Willingness and ability to comply with scheduled visits and other study procedures * Informed consent: Written informed consent obtained * Insurance: Patient is affiliated with a French health insurance plan Exclusion Criteria: * Tumors invading the pleura or mediastinum. * Concurrent infectious pneumonia or pericarditis. * Prior radiotherapy to the treatment field. * Presence of neoadjuvant treatment for the present cancer. * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Patients under guardianship, curatorship or safeguard of justice, * Pregnant or breast-feeding subjects * Concomitant participation or participation within the last 30 days in another clinical trial * Patient with an estimated life expectancy of less than 6 months.
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What it tests

  • Not listed
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Where

2 sites
Montpellier Cancer Institut
Montpellier, France
Lorraine Cancer Institute
Vandœuvre-lès-Nancy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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