LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial

Официальное название

LAttice Radiation Therapy for Large Lesions: Reggio Emilia Single-arm Phase II Trial (LART Trial)

Обзор

This study evaluates the activity and toxicity of Lattice Radiation Therapy (LRT) in patients with large, unresectable non-brain neoplastic lesions requiring palliative treatment. Eligible patients will 5 fractions LRT, delivered in every other day, to 20 Gy with a simultaneous boost to a minimum median dose of 50 Gy. No concomitant antineoplastic drugs will be allowed. Patients will be followed at 14, 30, 60, and 90 days after treatment, then every 3 months up to 1 year. Tumor response will be assessed using objective response rate (ORR) per RECIST 1.1, with CT scans at 3, 6, 9, and 12 months. Secondary endpoints include local control, toxicity (CTCAE v.5.0), and patient-reported outcomes (PROMs) to assess their quality of life (EORTC QLQ-C15-PAL and PRO-CTCAE). Exploratory objectives will assess the immunomodulatory effects of LRT through immune cell characterization and quantification of immune-related circulating factors before and after treatment.

Вмешательства

• Лучевая терапия 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).

Первичные конечные точки

• Objective Response Rate [Срок оценки: At 3 months following completion of Lattice radiation therapy]

Вторичные конечные точки (4)

• Local Control [Срок оценки: At 3, 6,9, and 12 months following completion of Lattice radiation therapy.]
• Treatment-related toxicity [Срок оценки: 1 year following completion of Lattice radiation therapy.]
• Patient-reported outcomes (Quality of life) [Срок оценки: 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year]
• Patient-reported outcomes (Quality of life) [Срок оценки: 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year]

Критерии участия

Критерии включения

• Age ≥18 on day signing informed consent
• 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

Критерии исключения

• Additional malignancy that is progressing or requires active treatment. Exceptions include basal and squamous cell carcinoma of the skin or in situ cervical
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Azienda USL IRCCS di Reggio Emilia — Reggio Emilia

Публикации

• 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
• 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. PMID 33064814
• 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. PMID 34195486
• 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. PMID 36590825
• 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
• 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. PMID 24246848
• 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. PMID 33142765
• 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. PMID 25036982

Идентификаторы

NCT: NCT07000162 · 5/2025/SPER/IRCCSRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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