Objective: Ultra-high dose rate FLASH radiotherapy (FLASH-RT) is emerging as a novel technique to improve the normal tissue tolerance by delivering ultra-high dose rate radiation several orders of magnitude higher than convention radiotherapy. It has been shown in preclinical studies to cause less injury to surrounding normal tissues during radiation treatment, while still maintaining local tumor control. The purpose of this protocol is to evaluate the safety of fractionated FLASH-RT in skin cancer.
Method: Patients with superficial skin tumors will be enrolled. The eligible patients will undergo electron FLASH-RT (24-40 Gy/3-5 fractions) to the tumor volume. The primary outcome is to evaluate the safety of FLASH-RT by collecting the acute (< 90 days) skin toxicity adverse events of radiation according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Secondary objectives include late (> 90 days) skin toxicity after FLASH-RT according to CTCAE version 5.0 and treatment response.
Discussion: If the results show that delivering FLASH-RT is safe and feasible for skin tumors, further investigation will be conduct to evaluate efficacy of FLASH-RT in a phase II trial.
Trial Registration number: ChiCTR2400080935. https://www.chictr.org.cn/showproj.html?proj=220336
| [1] |
Leiter U, Keim U, Garbe C. Epidemiology of Skin Cancer: Update 2019. Adv Exp Med Biol. 2020; 1268: 123-139.
|
| [2] |
Nestor MS, Berman B, Goldberg D, et al. Consensus Guidelines on the Use of Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancers and Keloids. J Clin Aesthet Dermatol. 2019; 12(2): 12-18.
|
| [3] |
Fiorino C, Guckemberger M, Schwarz M, van der Heide UA, Heijmen B. Technology-driven research for radiotherapy innovation. Mol Oncol. 2020; 14(7): 1500-1513.
|
| [4] |
Fendler W, Tomasik B, Atkins K, Stawiski K, Chałubińska-Fendler J, Kozono D. The clinician's guide to radiotherapy complications. Pol Arch Intern Med. 2022; 132(1): 16190.
|
| [5] |
Vozenin MC, Bourhis J, Durante M. Towards clinical translation of FLASH radiotherapy. Nat Rev Clin Oncol. 2022; 19(12): 791-803.
|
| [6] |
Vozenin MC, De Fornel P, Petersson K, et al. The Advantage of FLASH Radiotherapy Confirmed in Mini-pig and Cat-cancer Patients. Clin Cancer Res. 2019; 25(1): 35-42.
|
| [7] |
Gao F, Yang Y, Zhu H, et al. First demonstration of the FLASH effect with ultrahigh dose rate high-energy X-rays. Radiother Oncol. 2022; 166: 44-50.
|
| [8] |
Velalopoulou A, Karagounis IV, Cramer GM, et al. FLASH Proton Radiotherapy Spares Normal Epithelial and Mesenchymal Tissues While Preserving Sarcoma Response. Cancer Res. 2021; 81(18): 4808-4821.
|
| [9] |
Bourhis J, Sozzi WJ, Jorge PG, et al. Treatment of a first patient with FLASH-radiotherapy. Radiother Oncol. 2019; 39: 18-22.
|
| [10] |
Gaide O, Herrera F, Jeanneret SW, et al. Comparison of ultra-high versus conventional dose rate radiotherapy in a patient with cutaneous lymphoma. Radiother Oncol. 2022; 174: 87-91.
|
| [11] |
Mascia AE, Daugherty EC, Zhang Y, et al. Proton FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases: The FAST-01 Nonrandomized Trial. JAMA Oncol. 2023; 9(1): 62-69.
|
| [12] |
Luo H, Yan MY, Jia XC, et al. Application of FLASH radiotherapy with an ultra-high dose rate in malignant tumor. Chin J Radiologi Med Prot. 2021; 41(8): 636-640.
|
| [13] |
Schwartz LH, Litière S, de Vries E, et al. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016; 62: 132-137.
|
| [14] |
Ma LJ, Mao RH, Lei HC, et al. Transform routine medical accelerators to achieve Flash-RT and physical performance measurements. Chin J Radi Oncol. 2022; 31(11): 1022-1027.
|
| [15] |
Cives M, Mannavola F, Lospalluti L, et al. Non-Melanoma Skin Cancers: Biological and Clinical Features. Int J Mol Sci. 2020; 21(15): 5394.
|
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2025 The Author(s). Precision Radiation Oncology published by John Wiley & Sons Australia, Ltd on behalf of Shandong Cancer Hospital & Institute.
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