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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lattice radiation therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Percentage of patients with complete and partial response according to RECIST1.1 criteria | At 3 months following completion of Lattice radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | Percentage of patients with complete response, partial response, and stable disease according to RECIST1.1 criteria | At 3, 6,9, and 12 months following completion of Lattice radiation therapy. |
| Treatment-related toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Immunomodulatory effects of Lattice Radiation Therapy (LRT) | Modification compared to baseline of immune cells through cell immunophenotyping and immune-related circulating factors possibly associated with LRT compared to baseline (Exploratory Outcome) | 7-14 days after the end of the treatment |
Inclusion Criteria:
Reproductive Status
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Iori, MD | Contact | +39 0522 296261 | federico.iori@ausl.re.it |
| Name | Affiliation | Role |
|---|---|---|
| Cinzia Iotti, MD | Azienda USL - IRCCS di Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL IRCCS di Reggio Emilia | Recruiting | Reggio Emilia | Italy | 42123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31768424 | Background | 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. | |
| 33064814 | Background |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
Percentage of patients with treatment-related adverse events measured by CTCAE version 5.0
| 1 year following completion of Lattice radiation therapy. |
| Patient-reported outcomes (Quality of life) | Scores modification compared to baseline at questionnaire EORTC QLQ-C15-PAL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 - Palliative care version), a 15-item scale with scores ranging from 0 to 100. Higher scores on functional and global health status scales indicate better quality of life, while higher scores on symptom scales indicate worse symptom burden. | 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year |
| Patient-reported outcomes (Quality of life) | Scores modification compared to baseline at questionnaire PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events), a patient-reported outcome measure developed by the U.S. National Cancer Institute. Each item is scored on a 5-point scale (range: 0-4), where higher scores indicate greater symptom frequency, severity, or interference with daily activities. | 2 weeks, 30 days, 60 days, and 90 days, 6 months, 9 months, 1 year |
| 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. |
| 34195486 | Background | 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. |
| 36590825 | Background | 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. |
| 34875286 | Background | 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. |
| 24246848 | Background | 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. |
| 33142765 | Background | 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. |
| 25036982 | Background | 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. |
| 34209192 | Background | 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. |