Actively Recruiting

Age: 18Years +
All Genders
NCT07401615

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

Led by Istituto Clinico Humanitas · Updated on 2026-02-12

150

Participants Needed

11

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Inoperable primary non-small cell lung cancer or other metastatic lung tumors previously treated with radical dose SBRT
  • Inoperable local recurrence within the chest area confirmed by imaging or biopsy
  • Prior curative intent SBRT with a biologically equivalent dose of 75 Gy or higher
  • Stereotactic reirradiation with ablative intent given in up to 8 fractions
  • No active or controlled distant metastases at the time of reirradiation
  • At least 12 months since previous SBRT
  • Performance status (PS) of 2 or less
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

AST Papa Giovanni XXIII

Bergamo, Bergamo, Italy, 24127

Actively Recruiting

2

Radiotherapy Department, Ospedale Bellaria Carlo Alberto Pizzardi

Bologna, Bologna, Italy, 40124

Not Yet Recruiting

3

REM Radioterapia

Catania, Catania, Italy, 95125

Not Yet Recruiting

4

Radiation oncology unit, Ospedale San Raffaele

Milan, Milano, Italy, 20132

Not Yet Recruiting

5

Radiotherapy Department, Istituto Europeo di Oncologia

Milan, Milano, Italy, 20141

Not Yet Recruiting

6

IRCCS Humanitas Research Hospital

Rozzano, Milano, Italy, 20089

Actively Recruiting

7

Radiotherapy Department, IRCCS Istituto Nazionale Fondazione G. Pascale

Naples, Napoli, Italy, 80131

Not Yet Recruiting

8

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

Roma, Roma, Italy, 00136

Not Yet Recruiting

9

Radioterapia Oncologica - Ospedale dell'Angelo

Venezia, Venezia, Italy, 30174

Not Yet Recruiting

10

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

Negrar, Verona, Italy, 37024

Not Yet Recruiting

11

AOUI Verona, DAI Chirurgia e Oncologia - Radioterapia Oncologica

Verona, Verona, Italy, 37126

Not Yet Recruiting

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Research Team

D

Davide Franceschini, MD, radiation oncologist

CONTACT

L

Laura Bonavita, master degree

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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