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

NCT07441941 | Recruiting

• 2 other identifiers: PROICM 2024-03 SPA2025-A01702-47
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Oligometastatic Lung Tumor; NSCLC (Non-small Cell Lung Cancer); SBRT

Keywords

Quality of life; SBRT; Lung tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• To assess detailed quality of life (all dimension and symptoms)

  at baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

• To assess detailed quality of life (all dimension and symptoms)

  at baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

• To assess detailed quality of life (all dimension and symptoms)

  from baseline to 1 year after SBRT

• To assess detailed quality of life (all dimension and symptoms)

  from baseline to 1 year after SBRT

• To assess treatment efficacy

  From baseline to1 year after SBRT

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (2)

Montpellier Cancer Institut

Montpellier, ICM, 34298, France

RECRUITING

Lorraine Cancer Institute

Vandœuvre-lès-Nancy, 54519, France

NOT YET RECRUITING

Related Publications (9)

• 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.

  PMID: 31908301 BACKGROUND

• 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.

  PMID: 30982687 BACKGROUND

• 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.

  PMID: 25514807 BACKGROUND

• 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.

  PMID: 34048817 BACKGROUND

• 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.

  PMID: 31445956 BACKGROUND

• 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.

  PMID: 33840047 BACKGROUND

• 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.

  PMID: 26530743 BACKGROUND

• 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.

  PMID: 34455431 BACKGROUND

• 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.

  PMID: 28945875 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pierre Boisselier

  ICM Co. Ltd.

  STUDY CHAIR

Central Study Contacts

Aurore Moussion

CONTACT

0467613102; DRCI-soumissions@icm.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: March 2, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

FR (2)