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

Condition(s) studied

Study 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

Primary outcome measure(s)

• Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy — from baseline to 12 months after SBRT.
  Scores obtained on the scales of the EORTC QLQ-C30. Developed by the European Organisation for Research and Treatment of Cancer (EORTC), this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales, three symptom scales, a health/quality of life overall scale, and a number of additional elements assessing common symptoms, as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level
• Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy — from baseline to 12 months after SBRT.
  Scores obtained on the scales of the EORTC QLQ-LC29. Developed by the European Organisation for Research and Treatment of Cancer (EORTC), this self-reported questionnaire is a lung cancer-specific module designed to assess health-related quality of life in patients with lung cancer. The questionnaire includes multi-item scales and single-item measures assessing lung cancer-related symptoms, treatment-related side effects, as well as other disease- and treatment-associated symptoms. It also evaluates the impact of the disease and its treatment on daily activities and concerns related to disease progression. All scales and single-item measures are linearly transformed to a 0-100 scale. For symptom scales and single items, a higher score represents a higher level of symptoms or problems.

Trial sites (2)

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