Clinical trial · Interventional
SBRT-LATTICE-PATHY
Impact of Partial Stereotactic Body Radiotherapy in Hypoxic Segments of Large-volume Unresectable Tumors (SBRT-LATTICE-PATHY) - a Prospective Phase II Study.
NCT07645261CI-TRIAL-00114616recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer (Advanced Stage) | Malignant Neoplasm | ALIAS | 0.85 |
| Cancer (Solid Tumors) | Malignant Neoplasm | ALIAS | 0.85 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT-LATTICE-PATHY | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT-LATTICE-PATHY
- description
- 1 fraction of 24Gy in intratumoral vertices
- interventionNames
- Radiation: SBRT-LATTICE-PATHY
Primary outcomes (2)
- measure
- Rate of local control at 12 months
- timeFrame
- From enrollment to the end of treatment at 12 months
- description
- Percentage of participants achieving local control, defined as absence of local tumor progression assessed by imaging (CT).
- measure
- Tumor volume shrinkage at 12 months
- timeFrame
- From enrollment to the end of treatment at 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDKorpics 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
- BACKGROUNDAmendola 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
- BACKGROUNDYan 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
- BACKGROUNDIkeda 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
- BACKGROUNDDuriseti 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
- BACKGROUNDTubin 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.