SBRT-LATTICE-PATHY

NCT07645261 | Recruiting Phase 2 DMC

• 1 other identifier: 86859225.3.0000.0068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

SBRT; LATTICE; partial irradiation; large volume tumors

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 12-month overall survival rate

  12 months overall survival

• 12-month progression-free survival rate

  12 months Progression Free Survival

• Rate of acute adverse events assessed by CTCAE v 5.0

  15 days, 1 month and 3 months after treatment initiation

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

  6, 9 and 12 months after treatment completion

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

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

Study Arms (1)

SBRT-LATTICE-PATHY

EXPERIMENTAL

1 fraction of 24Gy in intratumoral vertices

Radiation: SBRT-LATTICE-PATHY

Interventions

SBRT-LATTICE-PATHY RADIATION

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

SBRT-LATTICE-PATHY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403905, Brazil

RECRUITING

Related Publications (7)

• 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.

  PMID: 37183819 BACKGROUND

• 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.

  PMID: 29594253 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.

  PMID: 31768424 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.

  PMID: 21382012 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.

  PMID: 34875286 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.

  PMID: 30696472 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.

  PMID: 29293036 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Heloisa de Andrade Carvalho, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

551126616722; heloisa.carvalho@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 06-03-2026 to 12-31-2028
• Access Criteria: 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.

Locations

BR (1)