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Cancer (Advanced Stage)Phase 2NCT07645261

SBRT-LATTICE-PATHY

A Phase 2 study testing SBRT-LATTICE-PATHY in people with Cancer (Advanced Stage) and Cancer (Solid Tumors), run by University of Sao Paulo General Hospital at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBRT-LATTICE-PATHY
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
28 Apr 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Principal Investigator contact

551126616722

heloisa.carvalho@hc.fm.usp.br

Brazil1 site, 1 recruiting

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

    São Paulo, São Paulo, 05403905

    Principal Investigator, 551126616722, heloisa.carvalho@hc.fm.usp.br

    Thiago Brasileiro de Freitas, MD

    Recruiting

Other trials in Brazil

About this study

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

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.

Being tested
SBRT-LATTICE-PATHY
Keywords
SBRT, LATTICE, partial irradiation, large volume tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRT-LATTICE-PATHYRadiation

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

Study groups in NCT07645261
Study groupRoleWhat they receive
SBRT-LATTICE-PATHYExperimental1 fraction of 24Gy in intratumoral vertices
Receives: Radiation: SBRT-LATTICE-PATHY

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of local control at 12 months

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

    Measured: From enrollment to the end of treatment at 12 months

  2. 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.

    Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (5)

  1. 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.

    Measured: 12 months overall survival

  2. 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.

    Measured: 12 months Progression Free Survival

  3. 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.

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

  4. 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.

    Measured: 6, 9 and 12 months after treatment completion

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start28 Apr 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07645261
Sponsor's protocol ID
86859225.3.0000.0068
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Spreadsheet data (RedCap), ICF

Publications

  • 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.

    PubMed 37183819

  • 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.

    PubMed 29594253

  • 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.

    PubMed 31768424

  • 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.

    PubMed 21382012

  • 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.

    PubMed 34875286

  • 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.

    PubMed 30696472

  • 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.

    PubMed 29293036

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT-LATTICE-PATHY in people with Cancer (Advanced Stage) and Cancer (Solid Tumors), run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Principal Investigator (551126616722, heloisa.carvalho@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of local control at 12 months (time frame: From enrollment to the end of treatment at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07645261, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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