Single‑session high‑dose lung radiotherapy and its effects on outcomes and quality of life
Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor
This study tests whether a single high‑dose session of SBRT (30–34 Gy) works and how it affects quality of life for adults with small primary non‑small cell lung cancers or up to three lung metastases who are inoperable or refuse surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Montpellier, ICM and 1 other locations) |
| Trial ID | NCT07441941 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study follows adults receiving single‑fraction stereotactic body radiotherapy (30–34 Gy) for peripheral lung tumors ≤3 cm that are inoperable or for patients with up to three lung metastases. Participants are enrolled at Montpellier and Lorraine cancer centers and undergo routine clinical follow‑up with imaging and standardized quality‑of‑life questionnaires. The study records local control, toxicity, survival outcomes, and patient‑reported quality of life to characterize real‑world effects of monofraction SBRT. Collected data aim to inform how single‑session treatment integrates into routine practice compared with multi‑fraction approaches.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with peripheral T1‑2 N0 M0 NSCLC or oligometastatic lung disease (≤3 metastases), tumor ≤3 cm and >2 cm from the proximal bronchial tree, inoperable or refusing surgery, with ECOG 0–2 and able to comply with follow‑up.
Not a fit: Patients with tumors invading the pleura or mediastinum, central tumors too close to major airways (<2 cm), prior radiotherapy to the treatment field, active pulmonary infection, or inability to follow study procedures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, results could support using single‑session SBRT to maintain tumor control while reducing clinic visits and preserving patients' quality of life.
How similar studies have performed: Previous SBRT series report high local control for early lung tumors, and COVID‑era monofraction protocols (30–34 Gy) have shown outcomes comparable to multi‑fraction regimens.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montpellier, ICM and 1 other locations
- Montpellier Cancer Institut — Montpellier, Icm, France (Recruiting)
- Lorraine Cancer Institute — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Aurore Moussion
- Email: DRCI-soumissions@icm.unicancer.fr
- Phone: 0467613102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.