A Phase 2 interventional study of SBRT-LATTICE-PATHY in Cancer (Advanced Stage), Cancer (Solid Tumors) and Tumor, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 fraction of 24Gy in intratumoral vertices
Radiation: SBRT-LATTICE-PATHY
SBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions.
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 months
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 months
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 survival
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 Survival
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 initiation
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 completion
Mean EORTC QLC-C30 Global Health Status / Quality of Life Score)
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.
Time frame: Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Spreadsheet data (RedCap), ICF
Supporting information: Study protocol, Icf
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University of Sao Paulo General Hospital