RecruitingPhase 2NCT07645261

SBRT-LATTICE-PATHY

Impact of Partial Stereotactic Body Radiotherapy in Hypoxic Segments of Large-volume Unresectable Tumors (SBRT-LATTICE-PATHY) - a Prospective Phase II Study.


Sponsor

University of Sao Paulo General Hospital

Enrollment

20 participants

Start Date

Apr 28, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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.

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Interventions

RADIATIONSBRT-LATTICE-PATHY

SBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions.


Locations(1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Radiologia

São Paulo, São Paulo, Brazil

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NCT07645261


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