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Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Montpellier Cancer Institut
RECRUITING
Montpellier
Lorraine Cancer Institute
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Aurore Moussion
DRCI-soumissions@icm.unicancer.fr
0467613102
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 190
Treatments
Prospective cohort
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.
Retrospective cohort
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.
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov

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