Repeat SBRT for Inoperable Recurrent Lung Tumors
Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Bergamo, Bergamo and 10 other locations) |
| Trial ID | NCT07401615 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bergamo, Bergamo and 10 other locations
- AST Papa Giovanni XXIII — Bergamo, Bergamo, 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)
- IRCCS Humanitas Research Hospital — Rozzano, Milano, Italy (Recruiting)
- 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
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.