LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial
NCT ID: NCT07000162
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2025-05-26
2028-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lattice radiation therapy
Radiation: A total dose will be 20 Gy, with a simultaneous boost to selected tumor regions (hot spots) reaching a minimum median dose of 50 Gy.
Lattice radiation therapy
A total dose will be 20 Gy, with a simultaneous boost to selected tumor regions (hot spots) reaching a minimum median dose of 50 Gy.
Peripheral blood (PB) samples for the immune cell characterization and quantification of immune-related circulating factors will be collected at baseline (pre-therapy) and within 7 -14 days after the end of the treatment (post-therapy).
Interventions
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Lattice radiation therapy
A total dose will be 20 Gy, with a simultaneous boost to selected tumor regions (hot spots) reaching a minimum median dose of 50 Gy.
Peripheral blood (PB) samples for the immune cell characterization and quantification of immune-related circulating factors will be collected at baseline (pre-therapy) and within 7 -14 days after the end of the treatment (post-therapy).
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed cancer.
* Performance status of 0-2 on the ECOG Performance Scale.
* Advanced or locally advanced disease, not eligible for curative-intent treatment.
* Life expectancy \> 6 months.
* At least one measurable non-brain site of disease with a diameter ≥ 4.5 cm, in any direction
* Ability to understand and willingness to sign the written informed consent document (or that of legally authorized representative, if applicable).
Reproductive Status
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of LRT.
* Women must not be breastfeeding.
* WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 30 days (duration of ovulatory cycle).
* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of LRT plus 90 days (duration of sperm turnover).
* Investigators shall counsel WOCBP patients and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy
Exclusion Criteria
* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the start of LRT.
* Prior high-dose radiotherapy overlapping with any planned site of protocol radiotherapy, if the dose overlap is \> 10 Gy or is determined not safe by the treating physician.
* HIV patients with CD4+ T-cell counts \< 350 cells/mcL or with a history of AIDS-defining opportunistic infection, within the 12 months prior to registration
18 Years
ALL
No
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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Principal Investigators
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Cinzia Iotti, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda USL - IRCCS di Reggio Emilia
Locations
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Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Wu X, Perez NC, Zheng Y, Li X, Jiang L, Amendola BE, Xu B, Mayr NA, Lu JJ, Hatoum GF, Zhang H, Chang SX, Griffin RJ, Guha C. The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). Radiat Res. 2020 Dec 1;194(6):737-746. doi: 10.1667/RADE-20-00066.1.
Duriseti S, Kavanaugh J, Goddu S, Price A, Knutson N, Reynoso F, Michalski J, Mutic S, Robinson C, Spraker MB. Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. Adv Radiat Oncol. 2021 Jan 8;6(3):100639. doi: 10.1016/j.adro.2020.100639. eCollection 2021 May-Jun.
Iori F, Cappelli A, D'Angelo E, Cozzi S, Ghersi SF, De Felice F, Ciammella P, Bruni A, Iotti C. Lattice Radiation Therapy in clinical practice: A systematic review. Clin Transl Radiat Oncol. 2022 Dec 20;39:100569. doi: 10.1016/j.ctro.2022.100569. eCollection 2023 Mar.
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.
Asur R, Butterworth KT, Penagaricano JA, Prise KM, Griffin RJ. High dose bystander effects in spatially fractionated radiation therapy. Cancer Lett. 2015 Jan 1;356(1):52-7. doi: 10.1016/j.canlet.2013.10.032. Epub 2013 Nov 15.
Kumari S, Mukherjee S, Sinha D, Abdisalaam S, Krishnan S, Asaithamby A. Immunomodulatory Effects of Radiotherapy. Int J Mol Sci. 2020 Oct 31;21(21):8151. doi: 10.3390/ijms21218151.
Kanagavelu S, Gupta S, Wu X, Philip S, Wattenberg MM, Hodge JW, Couto MD, Chung KD, Ahmed MM. In vivo effects of lattice radiation therapy on local and distant lung cancer: potential role of immunomodulation. Radiat Res. 2014 Aug;182(2):149-62. doi: 10.1667/RR3819.1. Epub 2014 Jul 18.
Ferini G, Valenti V, Tripoli A, Illari SI, Molino L, Parisi S, Cacciola A, Lillo S, Giuffrida D, Pergolizzi S. Lattice or Oxygen-Guided Radiotherapy: What If They Converge? Possible Future Directions in the Era of Immunotherapy. Cancers (Basel). 2021 Jun 30;13(13):3290. doi: 10.3390/cancers13133290.
Other Identifiers
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5/2025/SPER/IRCCSRE
Identifier Type: -
Identifier Source: org_study_id
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