Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions

February 10, 2026 updated by: Istituto Clinico Humanitas

Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)

Radiotherapy (radiation treatment) is often used to treat lung cancers and lung tumors that have spread from other cancers. It can be very effective, especially in early-stage lung cancer or when there are only a few tumor sites. Even so, some patients later develop a local recurrence, meaning the cancer comes back in the same area that was previously treated with radiation.

When this happens, treatment options are limited. Surgery can sometimes remove the recurrent tumor, but many patients are not able to have surgery because of their general health or because the tumor is difficult to remove. For these patients, a second course of radiotherapy (called re-irradiation) may be the only possible treatment. One type of radiotherapy, called stereotactic body radiotherapy (SBRT), delivers very high doses of radiation very precisely. SBRT has been used successfully as a second treatment after standard radiotherapy in some patients. However, there is very little information about using SBRT again in patients who already received SBRT the first time.

Because only small studies have been done and the patients were very different from each other, doctors still do not know enough about how safe and effective a second SBRT treatment is. In particular, it is still unclear whether giving another high-dose radiation treatment is possible without causing serious side effects. More research is needed to better understand this option and help guide treatment decisions for patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Bergamo
      • Bergamo, Bergamo, Italy, 24127
        • Recruiting
        • AST Papa Giovanni XXIII
        • Contact:
    • Bologna
      • Bologna, Bologna, Italy, 40124
        • Not yet recruiting
        • Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi
        • Contact:
    • Catania
      • Catania, Catania, Italy, 95125
    • Milano
      • Milan, Milano, Italy, 20132
        • Not yet recruiting
        • Radiation oncology unit, Ospedale San Raffaele
        • Contact:
      • Milan, Milano, Italy, 20141
        • Not yet recruiting
        • Radiotherapy Department, Istituto Europeo di Oncologia
        • Contact:
      • Rozzano, Milano, Italy, 20089
    • Napoli
      • Napoli, Napoli, Italy, 80131
    • Roma
      • Roma, Roma, Italy, 00136
        • Not yet recruiting
        • Centro Fondazione Policlinico Universitario "A. Gemelli", Radioterapia Oncologica
        • Contact:
    • Venezia
      • Venezia, Venezia, Italy, 30174
    • Verona
      • Negrar, Verona, Italy, 37024
        • Not yet recruiting
        • Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center
        • Contact:
      • Verona, Verona, Italy, 37126
        • Not yet recruiting
        • AOUI Verona, DAI Chirurgia e Oncologia - Radioterapia Oncologica
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients treated with Pulmonary stereotactic radiotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
re-irradiation SBRT
Patients treated with re-irradiation SBRT on non small cell lung carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: from treatment to 1 years follow up
evaluation of treatment safety through toxicities according to the CACTE scale
from treatment to 1 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to new systemic treatment
Time Frame: from enrollment to 1 years follow up
time from the first day of SBRT to change or starting of new systemic therapies
from enrollment to 1 years follow up
Progression free survival
Time Frame: from enrollment to 1 years follow up
time from the first day of SABR until the date of detection of progressive disease (in-field or out-field) or death, whichever occurred first.
from enrollment to 1 years follow up
Overall survival
Time Frame: from enrollment to 1 years follow up
time from the first day of SABR to death. Patients lost to follow-up have their OS censored at the last date they were known to be alive
from enrollment to 1 years follow up
Dosimetric parameters related to treatment toxicity
Time Frame: from enrollment to 1 years follow up
analysis between correlation between treatment dosage and occurrence of toxicity
from enrollment to 1 years follow up
Number of partecipant with local control
Time Frame: from enrollment to 1 years follow up
defined as the absence of progression within the field of SABR, assessed by contrast-enhanced CT scan
from enrollment to 1 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRILL IT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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