SBRT-LATTICE-PATHY
8 juni 2026 uppdaterad av: Heloísa de Andrade Carvalho, University of Sao Paulo General Hospital
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Principal Investigator
- Telefonnummer: 551126616722
- E-post: heloisa.carvalho@hc.fm.usp.br
Studieorter
-
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São Paulo
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São Paulo, São Paulo, Brasilien, 05403905
- Rekrytering
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Radiologia
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Kontakt:
- Principal Investigator
- Telefonnummer: 551126616722
- E-post: heloisa.carvalho@hc.fm.usp.br
-
Underutredare:
- Thiago Brasileiro de Freitas, MD
-
Underutredare:
- Silvio Thiago Pereira Vasconcelos, MD
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Underutredare:
- Caroline Castilhano Sampaio, Medical physicist
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: SBRT-LATTICE-PATHY
1 fraction of 24Gy in intratumoral vertices
|
SBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of local control at 12 months
Tidsram: 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).
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From enrollment to the end of treatment at 12 months
|
|
Tumor volume shrinkage at 12 months
Tidsram: 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.
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From enrollment to the end of treatment at 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
12-month overall survival rate
Tidsram: 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.
|
12 months overall survival
|
|
12-month progression-free survival rate
Tidsram: 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.
|
12 months Progression Free Survival
|
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Rate of acute adverse events assessed by CTCAE v 5.0
Tidsram: 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.
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15 days, 1 month and 3 months after treatment initiation
|
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Rate of late adverse events assessed by CTCAE v5.0
Tidsram: 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.
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6, 9 and 12 months after treatment completion
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Mean EORTC QLC-C30 Global Health Status / Quality of Life Score)
Tidsram: Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion
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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.
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Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Heloisa de Andrade Carvalho, MD, PhD, University of Sao Paulo
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 april 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 86859225.3.0000.0068
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Spreadsheet data (RedCap), ICF
Tidsram för IPD-delning
06-03-2026 to 12-31-2028
Kriterier för IPD Sharing Access
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.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .