Stereotactic Body Radiotherapy (SBRT) for Reirradiation of Inoperable Lung Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous conventional RT
Reirradiation with palliative doses
Reirradiation with conventionally fractionated or mildly hypofractionated RT
Trial population
patients treated with Pulmonary stereotactic radiotherapy
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: re-irradiation SBRT
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
evaluation of treatment safety through toxicities according to the CACTE scale
Time frame
from treatment to 1 years follow upSecondary outcomes
1
Number of partecipant with local control
defined as the absence of progression within the field of SABR, assessed by contrast-enhanced CT scan
Time frame
from enrollment to 1 years follow up2
Time to new systemic treatment
time from the first day of SBRT to change or starting of new systemic therapies
Time frame
from enrollment to 1 years follow up3
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.
Time frame
from enrollment to 1 years follow up4
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
Time frame
from enrollment to 1 years follow upSponsors and contacts
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Source ClinicalTrials.gov