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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT-LATTICE-PATHY | Experimental | 1 fraction of 24Gy in intratumoral vertices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT-LATTICE-PATHY | Radiation | SBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local control at 12 months | Percentage of participants achieving local control, defined as absence of local tumor progression assessed by imaging (CT). | 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. | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months overall survival |
| 12-month progression-free survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | 551126616722 | heloisa.carvalho@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Heloisa de Andrade Carvalho, MD, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Radiologia | Recruiting | São Paulo | São Paulo | 05403905 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37183819 | Background | Korpics MC, Onderdonk BE, Dadey RE, Hara JH, Karapetyan L, Zha Y, Karrison TG, Olson AC, Fleming GF, Weichselbaum RR, Bao R, Chmura SJ, Luke JJ. Partial tumor irradiation plus pembrolizumab in treating large advanced solid tumor metastases. J Clin Invest. 2023 May 15;133(10):e162260. doi: 10.1172/JCI162260. | |
| 29594253 | Background |
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Spreadsheet data (RedCap), ICF
06-03-2026 to 12-31-2028
Reasearchers will be able to acess the IPD and supporting information. To have access, they must contact the principal investigator who will share the ICF and Study Protocol.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2025 | Jun 8, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2025 | Jun 8, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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. |
| 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. | 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. | 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. | Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion |
| Amendola BE, Perez NC, Wu X, Blanco Suarez JM, Lu JJ, Amendola M. Improved outcome of treating locally advanced lung cancer with the use of Lattice Radiotherapy (LRT): A case report. Clin Transl Radiat Oncol. 2018 Jan 12;9:68-71. doi: 10.1016/j.ctro.2018.01.003. eCollection 2018 Feb. |
| 31768424 | Background | Yan W, Khan MK, Wu X, Simone CB 2nd, Fan J, Gressen E, Zhang X, Limoli CL, Bahig H, Tubin S, Mourad WF. Spatially fractionated radiation therapy: History, present and the future. Clin Transl Radiat Oncol. 2019 Oct 22;20:30-38. doi: 10.1016/j.ctro.2019.10.004. eCollection 2020 Jan. No abstract available. |
| 21382012 | Background | Ikeda T, Sun L, Tsuruoka N, Ishigaki Y, Yoshitomi Y, Yoshitake Y, Yonekura H. Hypoxia down-regulates sFlt-1 (sVEGFR-1) expression in human microvascular endothelial cells by a mechanism involving mRNA alternative processing. Biochem J. 2011 Jun 1;436(2):399-407. doi: 10.1042/BJ20101490. |
| 34875286 | Background | Duriseti S, Kavanaugh JA, Szymanski J, Huang Y, Basarabescu F, Chaudhuri A, Henke L, Samson P, Lin A, Robinson C, Spraker MB. LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4. |
| 30696472 | Background | Tubin S, Popper HH, Brcic L. Novel stereotactic body radiation therapy (SBRT)-based partial tumor irradiation targeting hypoxic segment of bulky tumors (SBRT-PATHY): improvement of the radiotherapy outcome by exploiting the bystander and abscopal effects. Radiat Oncol. 2019 Jan 29;14(1):21. doi: 10.1186/s13014-019-1227-y. |
| 29293036 | Background | Tubin S, Ahmed MM, Gupta S. Radiation and hypoxia-induced non-targeted effects in normoxic and hypoxic conditions in human lung cancer cells. Int J Radiat Biol. 2018 Mar;94(3):199-211. doi: 10.1080/09553002.2018.1422085. Epub 2018 Jan 12. |