NCT07645261RecruitingPhase 2
Impact of Partial Stereotactic Body Radiotherapy in Hypoxic Segments of Large-volume Unresectable Tumors (SBRT-LATTICE-PATHY) - a Prospective Phase II Study.
University of Sao Paulo General Hospital1 site in 1 country20 target enrollmentStarted: April 28, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.);
- •Palliative Prognostic Index (PPI) =or< 2;
- •metastatic disease in the central nervous system (CNS), if present, controlled (up to 3 metastases, each up to 1 cm);
- •up to 5 extracranial distant metastases (nodal or extranodal) =or< 5 cm; signed Informed Consent Form (ICF).
Exclusion Criteria
- •cases in which tumor volume and/or the patient's clinical condition make adequate immobilization/simulation impossible;
- •previous local radiotherapy;
- •pregnant patients;
- •autoimmune diseases;
- •genetic instability syndromes;
- •ongoing systemic therapy;
- •renal insufficiency that prevents the use of iodinated contrast.
Investigators
Heloísa de Andrade Carvalho
Principal Investigator
University of Sao Paulo General Hospital
Study Sites (1)
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