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

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

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.

Study Overview

• Status: Recruiting
• Conditions: SBRT; NSCLC (Non-small Cell Lung Cancer); Oligometastatic Lung Tumor

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: Aurore Moussion; Phone Number: 0467613102; Email: DRCI-soumissions@icm.unicancer.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54519
    • Not yet recruiting
    • Lorraine Cancer Institute
    • Contact: Hélène Wendling; Phone Number: +33383598487; Email: h.wendling@nancy.unicancer.fr
    • Principal Investigator: Jean-Christophe Faivre
  • ICM
    • Montpellier, ICM, France, 34298
      • Recruiting
      • Montpellier Cancer Institut
      • Principal Investigator: Pierre Boisselier
      • Contact: Aurore Moussion; Phone Number: +33467613102; Email: DRCI-soumissions@icm.unicancer.fr
      • Contact: Gaulthier Poupin; Email: gaulthier.poupin@icm.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	from baseline to 12 months after SBRT.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)	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	from baseline to 1 year after SBRT
To assess treatment efficacy	Time to definitive deterioration (i.e. loss of at least 10 points)	From baseline to1 year after SBRT
To assess treatment efficacy	Pulmonary function test : Force Expiratory Volume (FEV)	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)	at baseline, 3 months and 6 months after SBRT
To assess treatment efficacy	rate of patient with stable disease or complete response	at 1 year after SBRT
To assess treatment efficacy	Progression-free survival (PFS)	at 1 year after SBRT
To assess treatment efficacy	Overall survival (OS)	From baseline to 1 year after SBRT
To assess treatment tolerance	Rate of grade < 3 and ≥ 3 toxicities (per CTCAE v5.0 criteria)	From baseline to 1 year after SBRT
To evaluate the dosimetric and physical characteristics of this treatment.	Dosimetric data : dose to target volume	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	During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
To evaluate the dosimetric and physical characteristics of this treatment.	Dosimetric data : session duration	During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: Pierre Boisselier, ICM Co. Ltd.

Publications and helpful links

General Publications

• Koller M, Hjermstad MJ, Tomaszewski KA, Tomaszewska IM, Hornslien K, Harle A, Arraras JI, Morag O, Pompili C, Ioannidis G, Georgiou M, Navarra C, Chie WC, Johnson CD, Himpel A, Schulz C, Bohrer T, Janssens A, Kulis D, Bottomley A. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients. Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.
• Palma 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.
• Guckenberger 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.
• Chang 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.
• Videtic 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.
• Singh 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.
• Alongi F, Nicosia L, Figlia V, De Sanctis V, Mazzola R, Giaj-Levra N, Reverberi C, Valeriani M, Osti MF. A multi-institutional analysis of fractionated versus single-fraction stereotactic body radiotherapy (SBRT) in the treatment of primary lung tumors: a comparison between two antipodal fractionations. Clin Transl Oncol. 2021 Oct;23(10):2133-2140. doi: 10.1007/s12094-021-02619-4. Epub 2021 Apr 10.
• Videtic GM, Hu C, Singh AK, Chang JY, Parker W, Olivier KR, Schild SE, Komaki R, Urbanic JJ, Timmerman RD, Choy H. A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer: NRG Oncology RTOG 0915 (NCCTG N0927). Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):757-64. doi: 10.1016/j.ijrobp.2015.07.2260. Epub 2015 Jul 17.
• Siva S, Bressel M, Mai T, Le H, Vinod S, de Silva H, Macdonald S, Skala M, Hardcastle N, Rezo A, Pryor D, Gill S, Higgs B, Wagenfuehr K, Montgomery R, Awad R, Chesson B, Eade T, Wong W, Sasso G, De Abreu Lourenco R, Kron T, Ball D, Neeson P; Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung (SAFRON) II Study Investigators. Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II): The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1476-1485. doi: 10.1001/jamaoncol.2021.2939.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; SBRT; Lung tumor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PROICM 2024-03 SPA; 2025-A01702-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No