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

NCT07401615 | Recruiting

• 1 other identifier: STRILL IT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Non Small Cell Lung Cancer; Pulmonary Stereotactic Radiotherapy

Keywords

non small cell lung cancer; pulmonary stereotactic radiotherapy; sbrt; re-irradiation

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  evaluation of treatment safety through toxicities according to the CACTE scale

  from treatment to 1 years follow up

Secondary Outcomes (5)

• Number of partecipant with local control

  from enrollment to 1 years follow up

• Time to new systemic treatment

  from enrollment to 1 years follow up

• Progression free survival

  from enrollment to 1 years follow up

• Overall survival

  from enrollment to 1 years follow up

• Dosimetric parameters related to treatment toxicity

  from enrollment to 1 years follow up

Study Arms (1)

re-irradiation SBRT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated with Pulmonary stereotactic radiotherapy

You may qualify if:

• 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

You may not qualify if:

• Previous conventional RT
• Reirradiation with palliative doses
• Reirradiation with conventionally fractionated or mildly hypofractionated RT

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (11)

AST Papa Giovanni XXIII

Bergamo, Bergamo, 24127, Italy

RECRUITING

Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi

Bologna, Bologna, 40124, Italy

NOT YET RECRUITING

REM Radioterapia

Catania, Catania, 95125, Italy

NOT YET RECRUITING

Radiation oncology unit, Ospedale San Raffaele

Milan, Milano, 20132, Italy

NOT YET RECRUITING

Radiotherapy Department, Istituto Europeo di Oncologia

Milan, Milano, 20141, Italy

NOT YET RECRUITING

IRCCS Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Radiotherapy Department, IRCCS Istituto Nazionale Fondazione G. Pascale

Naples, Napoli, 80131, Italy

NOT YET RECRUITING

Centro Fondazione Policlinico Universitario "A. Gemelli", Radioterapia Oncologica

Roma, Roma, 00136, Italy

NOT YET RECRUITING

Radioterapia Oncologica - Ospedale dell'Angelo

Venezia, Venezia, 30174, Italy

NOT YET RECRUITING

Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center

Negrar, Verona, 37024, Italy

NOT YET RECRUITING

AOUI Verona, DAI Chirurgia e Oncologia - Radioterapia Oncologica

Verona, Verona, 37126, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Davide Franceschini, MD, radiation oncologist

CONTACT

+39 0282247428; davide.franceschini@cancercenter.humanitas.it

Laura Bonavita, master degree

CONTACT

+39 0282247026; laura.bonavita@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (11)