Non Small Cell Lung CancerNCT07401615
Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions
An observational study of Non Small Cell Lung Cancer and Pulmonary Stereotactic Radiotherapy, run by Istituto Clinico Humanitas at 11 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Pulmonary Stereotactic Radiotherapy
- How many people
- 150 participants
- Where
- 11 sitesItaly
- Study dates
- 25 Nov 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with Pulmonary stereotactic radiotherapy
Who may be able to join
- 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
Who cannot join
- Previous conventional RT
- Reirradiation with palliative doses
- Reirradiation with conventionally fractionated or mildly hypofractionated RT
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Davide Franceschini, MD, radiation oncologist contact
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
AST Papa Giovanni XXIII
Bergamo, Bergamo, 24127
Suela Vukcaj, MD, Radiation oncologist, svukcaj@asst-pg23.it
- Not yet recruiting
Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi
Bologna, Bologna, 40124
Elisa D'Angelo, MD, radiation oncologist, elisa.dangelo@ausl.bologna.it
- Not yet recruiting
REM Radioterapia
Catania, Catania, 95125
Valentina Zagardo, MD; radiation oncologist, valentina.zagardo@gmail.com
- Not yet recruiting
Radiation oncology unit, Ospedale San Raffaele
Milan, Milano, 20132
Roberta Tumminieri, MD, radiation oncologist, tummineri.roberta@hsr.it
- Not yet recruiting
Radiotherapy Department, Istituto Europeo di Oncologia
Milan, Milano, 20141
Daniela Alterio, MD, radiation oncologist, daniela.alterio@ieo.it
- Not yet recruiting
Radiotherapy Department, IRCCS Istituto Nazionale Fondazione G. Pascale
Naples, Napoli, 80131
Esmeralda Scipilliti, MD, Radiation oncologist, esmeralda.scipilliti@istititutotumori.na.it
- Not yet recruiting
Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center
Negrar, Verona, 37024
Luca Nicosia, MD, radiation oncologist, Luca.nicosia@sacrocuore.it
- Not yet recruiting
Centro Fondazione Policlinico Universitario "A. Gemelli", Radioterapia Oncologica
Roma, Roma, 00136
Luca Boldrini, MD, radiation oncologist, luca.boldrini@policlinicogemelli.it
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089
Davide Franceschini, MD, radiation oncologist, +39 0282247428, davide.franceschini@cancercenter.humanitas.it
- Not yet recruiting
Radioterapia Oncologica - Ospedale dell'Angelo
Venezia, Venezia, 30174
Melissa Scricciolo, MD, Radiation Oncologist, melissa.scricciolo@aulss3.veneto.it
- Not yet recruiting
AOUI Verona, DAI Chirurgia e Oncologia - Radioterapia Oncologica
Verona, Verona, 37126
Valeria Dionisi, MD, Radiation oncologist, valeria.dionisi@aovr.veneto.it
About this study
Official title: 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.
- Keywords
- non small cell lung cancer, pulmonary stereotactic radiotherapy, sbrt, re-irradiation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| re-irradiation SBRT | Patients treated with re-irradiation SBRT on non small cell lung carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
evaluation of treatment safety through toxicities according to the CACTE scale
Measured: from treatment to 1 years follow up
Secondary outcomes (5)
Number of partecipant with local control
defined as the absence of progression within the field of SABR, assessed by contrast-enhanced CT scan
Measured: from enrollment to 1 years follow up
Time to new systemic treatment
time from the first day of SBRT to change or starting of new systemic therapies
Measured: from enrollment to 1 years follow up
Progression free survival
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.
Measured: from enrollment to 1 years follow up
Overall survival
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
Measured: from enrollment to 1 years follow up
Dosimetric parameters related to treatment toxicity
analysis between correlation between treatment dosage and occurrence of toxicity
Measured: from enrollment to 1 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start25 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401615
- Sponsor's protocol ID
- STRILL IT
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions: an Italian Multicenter Retrospective Analysis (STRILL IT)
- ClinicalTrials.gov ID
- NCT07401615
- Acronym / sponsor ID
- STRILL IT
- Keywords
- non small cell lung cancer, pulmonary stereotactic radiotherapy, sbrt, re-irradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| re-irradiation SBRT | – | –Patients treated with re-irradiation SBRT on non small cell lung carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with Pulmonary stereotactic radiotherapy
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Previous conventional RT
- Reirradiation with palliative doses
- Reirradiation with conventionally fractionated or mildly hypofractionated RT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide Franceschini, MD, radiation oncologist contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Pulmonary Stereotactic Radiotherapy, run by Istituto Clinico Humanitas at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide Franceschini, MD, radiation oncologist (+39 0282247428, davide.franceschini@cancercenter.humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: from treatment to 1 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.