Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup
Recruiting · NCT07441941 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed.
- Lorraine Cancer Institute - Vandœuvre-lès-Nancy, France
- Montpellier Cancer Institut - Montpellier, ICM, France