SBRT-LATTICE-PATHY
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
To assess the importance of using SBRT-LATTICE-PATHY for the radiotherapy treatment of large tumors that would be considered intractable by currently used standard techniques. In this present study, the investigators will have the possibility of combining SBRT and LATTICE techniques, incorporating the concept of hypoxic tissue irradiation, which are potential modulators of abscopal and bystander effects, performing partial punctual treatment in the vertex region, without the need for irradiation of the entire tissue volume, further improving safety in relation to possible toxicities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age =or> 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status < 2; benign and malignant tumors for which the use of radiotherapy is well established in the literature;
tumors =or> 340 cm³ or with a largest diameter =or> 7 cm;
no indication for any other type of treatment due to lack of proven clinical benefit (surgery, chemotherapy, standard radiotherapy, immunotherapy, targeted therapy, etc.);
Disqualifiers
cases in which tumor volume and/or the patient's clinical condition make adequate immobilization/simulation impossible;
previous local radiotherapy;
pregnant patients;
autoimmune diseases;
Trial design
Design model
Single group
Treatments tested in this trial
SBRT-LATTICE-PATHY
RadiationSBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: SBRT-LATTICE-PATHYExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of local control at 12 months
Percentage of participants achieving local control, defined as absence of local tumor progression assessed by imaging (CT).
Time frame
From enrollment to the end of treatment at 12 months2
Tumor volume shrinkage at 12 months
Percentage reduction in gross tumor volume (GTV) measured by CT at 12 months compared to baseline, calculated as \[(baseline volume - follow-up volume) / baseline volume\] × 100.
Time frame
From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
12-month overall survival rate
Percentage of participants alive at 12 months after treatment initiation. Overall survival is defined as the time from enrollment to death from any cause.
Time frame
12 months overall survival2
12-month progression-free survival rate
Percentage of participants alive and without disease progression at 12 months after treatment initiation. Progression is assessed by CT imaging. Time is measured from enrollment to the first documented disease progression or death from any cause, whichever occurs first.
Time frame
12 months Progression Free Survival3
Rate of acute adverse events assessed by CTCAE v 5.0
Incidence and severity of acute adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Reported as the percentage of participants experiencing grade ≥1 adverse events. Assessed at 15 days, 1 month, and 3 months after treatment initiation.
Time frame
15 days, 1 month and 3 months after treatment initiation4
Rate of late adverse events assessed by CTCAE v5.0
Incidence and severity of late adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Reported as the percentage of participants experiencing grade ≥1 adverse events. Assessed at 6, 9, and 12 months after treatment completion.
Time frame
6, 9 and 12 months after treatment completionSponsors and contacts
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Source ClinicalTrials.gov