Oligometastatic Lung TumorSPARROWNCT07441941
Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup
An observational study of Oligometastatic Lung Tumor and NSCLC (Non-small Cell Lung Cancer), run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Lung Tumor, NSCLC (Non-small Cell Lung Cancer), SBRT
- How many people
- 190 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jan 2026to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Montpellier Cancer Institut
Montpellier, ICM, 34298
Aurore Moussion, +33467613102, DRCI-soumissions@icm.unicancer.fr
Gaulthier Poupin, gaulthier.poupin@icm.unicancer.fr
- Not yet recruiting
Lorraine Cancer Institute
Vandœuvre-lès-Nancy, 54519
Hélène Wendling, +33383598487, h.wendling@nancy.unicancer.fr
Jean-Christophe Faivre
About this study
Official title: 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.
Read more
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.
Read the 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.
- Keywords
- Quality of life, SBRT, Lung tumor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: from baseline to 12 months after SBRT.
Secondary outcomes (14)
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
Measured: 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.
Measured: 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)
Measured: 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
Measured: from baseline to 1 year after SBRT
To assess treatment efficacy
Time to definitive deterioration (i.e. loss of at least 10 points)
Measured: From baseline to1 year after SBRT
To assess treatment efficacy
Pulmonary function test : Force Expiratory Volume (FEV)
Measured: 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)
Measured: at baseline, 3 months and 6 months after SBRT
To assess treatment efficacy
rate of patient with stable disease or complete response
Measured: at 1 year after SBRT
To assess treatment efficacy
Progression-free survival (PFS)
Measured: at 1 year after SBRT
To assess treatment efficacy
Overall survival (OS)
Measured: From baseline to 1 year after SBRT
To assess treatment tolerance
Rate of grade < 3 and ≥ 3 toxicities (per CTCAE v5.0 criteria)
Measured: From baseline to 1 year after SBRT
To evaluate the dosimetric and physical characteristics of this treatment.
Dosimetric data : dose to target volume
Measured: 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
Measured: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
To evaluate the dosimetric and physical characteristics of this treatment.
Dosimetric data : session duration
Measured: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start14 Jan 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic Lung TumorStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Boisselier, Study chair, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441941
- Sponsor's protocol ID
- PROICM 2024-03 SPA
- Other IDs
- 2025-A01702-47
- Acronym
- SPARROW
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31908301Palma 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.
PubMed 30982687Chang 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.
PubMed 25514807Videtic 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.
PubMed 34048817Singh 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.
PubMed 31445956Alongi 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.
PubMed 33840047Videtic 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.
PubMed 26530743Siva 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.
PubMed 34455431Koller 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.
PubMed 28945875
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor
- ClinicalTrials.gov ID
- NCT07441941
- Acronym / sponsor ID
- SPARROW / PROICM 2024-03 SPA
- Keywords
- Quality of life, SBRT, Lung tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy
Time frame: from baseline to 12 months after SBRT.
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
Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy
Time frame: from baseline to 12 months after SBRT.
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.
14 secondary outcomes
To assess detailed quality of life (all dimension and symptoms)
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)
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)
Time frame: from baseline to 1 year after SBRT
To assess detailed quality of life (all dimension and symptoms)
Time frame: from baseline to 1 year after SBRT
To assess treatment efficacy
Time frame: From baseline to1 year after SBRT
To assess treatment efficacy
Time frame: at baseline, 3 months and 6 months after SBRT
assessment of treament in terms of pulmonary function
Time frame: at baseline, 3 months and 6 months after SBRT
To assess treatment efficacy
Time frame: at 1 year after SBRT
To assess treatment efficacy
Time frame: at 1 year after SBRT
To assess treatment efficacy
Time frame: From baseline to 1 year after SBRT
To assess treatment tolerance
Time frame: From baseline to 1 year after SBRT
To evaluate the dosimetric and physical characteristics of this treatment.
Time frame: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
To evaluate the dosimetric and physical characteristics of this treatment.
Time frame: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
To evaluate the dosimetric and physical characteristics of this treatment.
Time frame: During Single-Fraction stereotactic radiotherapy (SF-SBRT) treatment session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 31908301Guckenberger 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.
- Background: PubMed 30982687Palma 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.
- Background: PubMed 25514807Chang 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.
- Background: PubMed 34048817Videtic 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.
- Background: PubMed 31445956Singh 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.
- Background: PubMed 33840047Alongi 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.
- Background: PubMed 26530743Videtic 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.
- Background: PubMed 34455431Siva 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.
- Background: PubMed 28945875Koller 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Boisselier study chair
ICM Co. Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Lung Tumor and NSCLC (Non-small Cell Lung Cancer), run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore Moussion (0467613102, DRCI-soumissions@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the global quality of life of single-fraction pulmonary stereotactic radiation therapy (time frame: from baseline to 12 months after SBRT.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07441941, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.