Actively Recruiting

Age: 18Years +
All Genders
NCT07441941

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

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-03-02

190

Participants Needed

2

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Receiving single-fraction stereotactic body radiation therapy (SBRT)
  • Diagnosed with stage T1-2 N0 M0 non-small cell lung cancer (NSCLC) or oligometastatic lung tumor with 3 or fewer lung metastases
  • Tumor is inoperable or patient refuses surgery
  • Tumor size is 3 cm or smaller
  • Peripheral tumors located more than 2 cm from the proximal bronchial tree and at least 0.5 cm from the lung wall
  • Histological confirmation or diagnosis based on CT and PET scan evolution criteria
  • ECOG performance status between 0 and 2
  • Willing and able to comply with study visits and procedures
  • Provided written informed consent
  • Affiliated with a French health insurance plan
Not Eligible

You will not qualify if you...

  • Tumors invading the pleura or mediastinum
  • Presence of active infectious pneumonia or pericarditis
  • Previous radiotherapy to the treatment area
  • Receiving neoadjuvant treatment for this cancer
  • Substance abuse or medical, psychological, or social conditions interfering with participation or study evaluation
  • Under legal guardianship, curatorship, or safeguard of justice
  • Pregnant or breastfeeding
  • Participation in another clinical trial currently or within the last 30 days
  • Life expectancy estimated to be less than 6 months

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Montpellier Cancer Institut

Montpellier, ICM, France, 34298

Actively Recruiting

2

Lorraine Cancer Institute

Vandœuvre-lès-Nancy, France, 54519

Not Yet Recruiting

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Research Team

A

Aurore Moussion

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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