Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer, Pulmonary Stereotactic Radiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)
Overview
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.
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: from treatment to 1 years follow up]
Secondary outcome measures (5)
- Number of partecipant with local control [Time frame: from enrollment to 1 years follow up]
- Time to new systemic treatment [Time frame: from enrollment to 1 years follow up]
- Progression free survival [Time frame: from enrollment to 1 years follow up]
- Overall survival [Time frame: from enrollment to 1 years follow up]
- Dosimetric parameters related to treatment toxicity [Time frame: from enrollment to 1 years follow up]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 11 centers
- AST Papa Giovanni XXIII — Bergamo
- Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi — Bologna
- REM Radioterapia — Catania
- Radiation oncology unit, Ospedale San Raffaele — Milan
- Radiotherapy Department, Istituto Europeo di Oncologia — Milan
- IRCCS Humanitas Research Hospital — Rozzano
- Radiotherapy Department, IRCCS Istituto Nazionale Fondazione G. Pascale — Naples
- Centro Fondazione Policlinico Universitario "A. Gemelli", Radioterapia Oncologica — Roma
- … and 3 more centers
Identifiers
NCT: NCT07401615 · STRILL IT