Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorIstituto Clinico Humanitas
Academic / other
Drugs / interventionsradiation
Locations11 sites (Bergamo, Bergamo and 10 other locations)
StatusRecruiting
StartedNovember 25, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedFebruary 12, 2026
Trial IDNCT07401615 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.