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NCT Number: NCT07645261

SBRT-LATTICE-PATHY

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.

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Key information

Conditions

Cancer (Advanced Stage) Cancer (Solid Tumors) Neoplasms Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

São Paulo, 05403905, Brazil

Location status: Recruiting

Location contact

Caroline Castilhano Sampaio, Medical physicist

SUB_INVESTIGATOR

Principal Investigator

CONTACT

[email protected]

551126616722

Silvio Thiago Pereira Vasconcelos, MD

SUB_INVESTIGATOR

Thiago Brasileiro de Freitas, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SBRT-LATTICE-PATHY

Radiation

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

Primary outcomes

  1. Rate of local control at 12 months

    Time frame: From enrollment to the end of treatment at 12 months

    Percentage of participants achieving local control, defined as absence of local tumor progression assessed by imaging (CT).

  2. Tumor volume shrinkage at 12 months

    Time frame: From enrollment to the end of treatment 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.

Secondary outcomes

  1. 12-month overall survival rate

    Time frame: 12 months overall survival

    Percentage of participants alive at 12 months after treatment initiation. Overall survival is defined as the time from enrollment to death from any cause.

  2. 12-month progression-free survival rate

    Time frame: 12 months Progression Free Survival

    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.

  3. Rate of acute adverse events assessed by CTCAE v 5.0

    Time frame: 15 days, 1 month and 3 months after treatment initiation

    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.

  4. Rate of late adverse events assessed by CTCAE v5.0

    Time frame: 6, 9 and 12 months after treatment completion

    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.

  5. Mean EORTC QLC-C30 Global Health Status / Quality of Life Score)

    Time frame: Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion

    Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The Global Health Status/QoL subscale is scored from 0 to 100, where higher scores indicate better quality of life. Assessed at 1, 3, 6, 9, and 12 months after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

551126616722

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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