Clinical trial · Observational
Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup
Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Oligometastatic Lung Tumor | Lung Neoplasm | PROBABILISTIC | 0.70 |
| SBRT | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Prospective cohort
- description
- 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.
- label
- Retrospective cohort
- description
- 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.
Primary outcomes (2)
- measure
- Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDGuckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1. PMID 31908301
- BACKGROUNDPalma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11. PMID 30982687
- BACKGROUNDChang JY, Bezjak A, Mornex F; IASLC Advanced Radiation Technology Committee. Stereotactic ablative radiotherapy for centrally located early stage non-small-cell lung cancer: what we have learned. J Thorac Oncol. 2015 Apr;10(4):577-85. doi: 10.1097/JTO.0000000000000453. PMID 25514807
- BACKGROUNDVidetic GMM, Reddy CA, Woody NM, Stephans KL. Ten-Year Experience in Implementing Single-Fraction Lung SBRT for Medically Inoperable Early-Stage Lung Cancer. Int J Radiat Oncol Biol Phys. 2021 Oct 1;111(2):436-442. doi: 10.1016/j.ijrobp.2021.05.116. Epub 2021 May 26. PMID 34048817
- BACKGROUNDSingh AK, Gomez-Suescun JA, Stephans KL, Bogart JA, Hermann GM, Tian L, Groman A, Videtic GM. One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2019 Nov 15;105(4):752-759. doi: 10.1016/j.ijrobp.2019.08.019. Epub 2019 Aug 22. PMID 31445956