Repeat SBRT for Inoperable Recurrent Lung Tumors
Official title: Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)
Run by Istituto Clinico Humanitas · NCT07401615 · Data updated 2026-11-12
This project will try repeat stereotactic body radiotherapy (SBRT) to treat people with inoperable non-small cell lung cancer that has come back in an area previously treated with SBRT.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Bergamo, Bergamo and 10 other locations) |
| Status | Recruiting |
| Started | November 25, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07401615 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with an inoperable local recurrence overlapping the prior SBRT field at least 12 months after a prior curative SBRT (BED ≥75 Gy), with ECOG/PS ≤2 and no uncontrolled distant disease.
✕Probably not a fit
Patients who previously received conventional external-beam radiotherapy, require palliative-dose or conventionally fractionated re-irradiation, have recurrence within 12 months, or have uncontrolled metastatic disease are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol describes stereotactic re-irradiation for patients with inoperable local recurrence of non-small cell lung cancer or lung metastases after prior curative SBRT. Eligible patients must have a recurrence overlapping the previous 50% isodose, have received a prior SBRT with a biologically equivalent dose ≥75 Gy, be at least 12 months from prior treatment, and have performance status ≤2 with no active or uncontrolled distant metastases. Re-irradiation is delivered with ablative intent in up to 8 fractions, while patients previously treated with conventional radiotherapy or receiving palliative/conventional re-irradiation are excluded. Participating centers are located in Bergamo, Bologna, and Catania, Italy, and outcomes will focus on local control and treatment-related toxicity after stereotactic re-irradiation.
Why it matters
Potential benefit: If successful, repeat SBRT could provide durable local tumor control with acceptable side effects for patients who cannot undergo surgery.
How similar studies have gone: Several small retrospective series and single-center reports have reported promising local control and manageable toxicity with SBRT re-irradiation, but prospective evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose SBRT * Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and/or pathological biopsies within the thoracic area * Patients had previously received curative intent SBRT with a biologically equivalent dose equal or higher than 75 Gy * Stereotactic reirradiation with ablative purposes up to 8 fractions * No active distant metastasis or controlled distant metastasis at the time of re-irradiation * More than 12 months from previous SBRT * PS ≤ 2 Exclusion Criteria: * Previous conventional RT * Reirradiation with palliative doses * Reirradiation with conventionally fractionated or mildly hypofractionated RT
Where it's running
-
AST Papa Giovanni XXIII
Bergamo, Bergamo, Italy Recruiting -
IRCCS Humanitas Research Hospital
Rozzano, Milano, Italy Recruiting -
Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi
Bologna, Bologna, Italy Not yet recruiting -
REM Radioterapia
Catania, Catania, Italy Not yet recruiting -
Radiation oncology unit, Ospedale San Raffaele
Milan, Milano, Italy Not yet recruiting -
Radiotherapy Department, Istituto Europeo di Oncologia
Milan, Milano, Italy Not yet recruiting
Show 5 more locations
-
Radiotherapy Department, IRCCS Istituto Nazionale Fondazione G. Pascale
Naples, Napoli, Italy Not yet recruiting -
Centro Fondazione Policlinico Universitario "A. Gemelli", Radioterapia Oncologica
Roma, Roma, Italy Not yet recruiting -
Radioterapia Oncologica - Ospedale dell'Angelo
Venezia, Venezia, Italy Not yet recruiting -
Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center
Negrar, Verona, Italy Not yet recruiting -
AOUI Verona, DAI Chirurgia e Oncologia - Radioterapia Oncologica
Verona, Verona, Italy Not yet recruiting
Study contacts
- Study coordinator: Davide Franceschini, MD, radiation oncologist
- Email: davide.franceschini@cancercenter.humanitas.it
- Phone: +39 0282247428
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Patient-specific MRD liquid biopsy for resected NSCLC
This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.
-
Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
-
Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies
This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.
-
SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
-
Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery
This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.
-
HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.