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NCT Number: NCT07401615

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AST Papa Giovanni XXIII, Bergamo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Franceschini, MD, radiation oncologist

CONTACT

[email protected]

+39 0282247428

Laura Bonavita, master degree

CONTACT

[email protected]

+39 0282247026

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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