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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

190 Participants
are grouped into 2 trial groups