An observational study in Oligometastatic Lung Tumor, NSCLC (Non-small Cell Lung Cancer) and SBRT, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Observational
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.
Pulmonary tumors, whether primary or metastatic, represent a major challenge in oncology. Lung cancer remains the leading cause of cancer-related mortality in France, with nearly 37,000 annual deaths. Pulmonary metastases, present in approximately 20% of patients with solid tumors, highlight the complexity of managing secondary tumors, particularly in the context of oligometastatic cancers. These cancers, characterized by a limited number of metastases (generally ≤3 to 5), have garnered increasing attention due to their potentially improved prognosis with the use of local ablative therapies.
Stereotactic body radiotherapy (SBRT) is a technique that delivers high doses of radiation with great precision over a limited number of sessions (1 to 5 fractions compared to around 30 in conventional radiotherapy). For primary lesions, SBRT has demonstrated local control rates exceeding 90% and a 5-year survival rate of 87% (Chang et al., 2015). Similarly, promising outcomes have been reported for oligometastatic pulmonary lesions, with improvements in progression-free and overall survival compared to standard of care. Consequently, SBRT has become a key therapeutic option for pulmonary tumors, whether primary or secondary.
During the recent COVID-19 pandemic, monofraction protocols (30 or 34 Gy) were implemented. Their equivalence has been demonstrated for both primary lesions and secondary lesions, and they have been included in clinical guidelines. Single-session treatments are particularly advantageous for patients with poor general health or those living far from treatment centers, as they help to minimize travel requirements.
However, although SBRT in a single fraction offers promising prospects, data on its impact on quality of life remain limited, especially for patients with non-small cell lung cancer. Such information is crucial to guide the integration of this strategy into clinical practice and to assess its benefits in the context of personalized care.
This bicentric ambispective observational study (RIPH 3 according to the Jardé Law) aims to evaluate the quality of life of patients treated with single-fraction pulmonary SBRT using the EORTC QLQ C30 and LC-29 questionnaires. The primary endpoint will be analyzed prospectively in newly treated patients, while retrospective data will be included for secondary endpoints: tolerance (specifically grade ≥ 3 toxicities), efficacy (local control, progression-free survival, overall survival), and dosimetric parameters. The study involves patients with primitive (NSCLC T1-2N0) or oligometastatic (≤ 3 tumors) lung tumor who are inoperable or refuse surgery, treated with stereotactic radiotherapy delivering 34 Gy in a single session at two cancer centers (Institut de Cancérologie de Montpellier and Institut de Cancérologie de Lorraine). Patients will be asked to complete standardized quality-of-life questionnaires in French, the EORTC QLQ C30 and LC-29, pre-treatment, at M1, M3, M6, M9 and M12. These questionnaire completion times correspond to standard radiological assessments as part of the patient's medical management and follow-up.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 190 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 138 studies on the registry; 47 are open to participants now.
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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.
Exclusion Criteria:
During their usual care pathway for the management of their disease, patients will be seen in consultation by the department's radiation oncologist. If the inclusion criteria are met, the physician will offer them the opportunity to participate in the study. An information sheet will be provided, detailing the objectives, procedures, and any potential constraints related to their participation. Patients will have an appropriate reflection period to make their decision, in accordance with current recommendations. During this period, the investigator physician will remain available to answer any questions they may have. Once the informed consent form is signed and after a thorough verification of inclusion and exclusion criteria, the patient may be included in the study and benefit from the specific follow-up procedures outlined in the protocol.
For the retrospective part of the study, no direct contact with patients is planned. Clinical, dosimetric, tolerance, and any other data necessary to meet the study objectives will be collected from the medical records of patients previously treated with single-fraction SBRT at the ICM or ICL and who meet the study eligibility criteria. An information letter detailing the study objectives will be sent to patients. If a patient objects, the data will not be used in the study.
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.
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.
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 12
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 12
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 SBRT
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 SBRT
To assess treatment efficacy
Time to definitive deterioration (i.e. loss of at least 10 points)
Time frame: From baseline to1 year after SBRT
To assess treatment efficacy
Pulmonary function test : Force Expiratory Volume (FEV)
Time frame: at baseline, 3 months and 6 months after SBRT
assessment of treament in terms of pulmonary function
Pulmonary function test : Lung Diffusion Test / Diffusing Capacity for Carbon Monoxide (DLCO)
Time frame: at baseline, 3 months and 6 months after SBRT
To assess treatment efficacy
rate of patient with stable disease or complete response
Time frame: at 1 year after SBRT
To assess treatment efficacy
Progression-free survival (PFS)
Time frame: at 1 year after SBRT
To assess treatment efficacy
Overall survival (OS)
Time frame: From baseline to 1 year after SBRT
To assess treatment tolerance
Rate of grade \< 3 and ≥ 3 toxicities (per CTCAE v5.0 criteria)
Time frame: From baseline to 1 year after SBRT
To evaluate the dosimetric and physical characteristics of this treatment.
Dosimetric data : dose to target volume
Time frame: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
To evaluate the dosimetric and physical characteristics of this treatment.
Dosimetric data : dose to organs at risk
Time frame: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
To evaluate the dosimetric and physical characteristics of this treatment.
Dosimetric data : session duration
Time frame: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
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