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
This trial does not accept healthy volunteersQualifiers
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 population
Prospective part: The target population for the prospective part of the study consists of patients aged 18 years or older, treated at ICM or ICL for peripheral T1-2 N0 non-small cell lung carcinoma or non-operable oligometastatic secondary lesions, managed with stereotactic body radiotherapy (SBRT). Retrospective part: The target population for the retrospective part of the study consists of patients aged 18 years or older, treated at ICM or ICL for peripheral T1-2 N0 non-small cell lung carcinoma or non-operable oligometastatic secondary lesions, managed with stereotactic body radiotherapy (SBRT) between July 2020 and August 2025.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
190 Participants
are grouped into 2 trial groupsGroup A: Prospective cohort
Group B: Retrospective cohort
Trial outcomes
Primary outcomes
1
Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy
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
Time frame
from baseline to 12 months after SBRT.2
Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy
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.
Time frame
from baseline to 12 months after SBRT.Secondary outcomes
1
To assess detailed quality of life (all dimension and symptoms)
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
Time frame
at baseline, Month 1, Month 3, Month 6, Month 9, and Month 122
To assess detailed quality of life (all dimension and symptoms)
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.
Time frame
at baseline, Month 1, Month 3, Month 6, Month 9, and Month 123
To assess detailed quality of life (all dimension and symptoms)
Proportion of patients showing a decrease of at least 10 points in quality-of-life scores on the EORTC QLQ-C30 (global quality of life)
Time frame
from baseline to 1 year after SBRT4
To assess detailed quality of life (all dimension and symptoms)
Proportion of patients showing a decrease of at least 10 points in quality-of-life scores on the EORTC LC-29 (lung cancer-specific module) questionnaires
Time frame
from baseline to 1 year after SBRTSponsors and contacts
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Source ClinicalTrials.gov