Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

Официальное название

Efficacy of Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

Обзор

This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.

Подробное описание

The patients with gynecological cancer treated with Advanced Radiotherapy (ART)- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- at the Department of Radiotherapy of "IRCCS San Raffaele Scientific Institute" (IRCCSSRaffaele) from January 2005 to January 2024 will be identified and their clinical and dosimetric data retrieved and analyzed.

The study objectives are the analysis of acute and late toxicity, and clinical outcomes, such as local, regional and distant control,disease free survival, cancer-specific survival, and overall survival. Secondary objective is the identification of prognostic factors for toxicity, disease progression, survival, including radiomic characteristics.

Вмешательства

• Лучевая терапия Image Guided Radiotherapy
  Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated

Первичные конечные точки

• Local Relapse Free Survival [Срок оценки: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months]
• Regional Relapse Free Survival [Срок оценки: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months]
• Distant Metastases Free Survival [Срок оценки: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months]
• Disease Free Survival [Срок оценки: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months]
• Overall Survival [Срок оценки: From date of radiotherapy end until the date of death from any cause, assessed up to 120 months]
• Cancer Specific Survival [Срок оценки: From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months]

Вторичные конечные точки (2)

• Acute toxicity [Срок оценки: Up to three months from the start of radiotherapy]
• Late toxicity [Срок оценки: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months]

Критерии участия

Критерии включения

• gynecologic cancer patients
• >18 years old
• treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)

Критерии исключения

• other tumors
• > 90 years old

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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• San Raffaele Scientific Institute — Milan

Публикации

• Gavinski K, DiNardo D. Cervical Cancer Screening. Med Clin North Am. 2023 Mar;107(2):259-269. doi: 10.1016/j.mcna.2022.10.006. Epub 2022 Dec 26. PMID 36759096
• Stewart C, Ralyea C, Lockwood S. Ovarian Cancer: An Integrated Review. Semin Oncol Nurs. 2019 Apr;35(2):151-156. doi: 10.1016/j.soncn.2019.02.001. Epub 2019 Mar 11. PMID 30867104
• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. PMID 35020204
• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
• Makker V, MacKay H, Ray-Coquard I, Levine DA, Westin SN, Aoki D, Oaknin A. Endometrial cancer. Nat Rev Dis Primers. 2021 Dec 9;7(1):88. doi: 10.1038/s41572-021-00324-8. PMID 34887451
• Berek JS, Matias-Guiu X, Creutzberg C, Fotopoulou C, Gaffney D, Kehoe S, Lindemann K, Mutch D, Concin N; Endometrial Cancer Staging Subcommittee, FIGO Women's Cancer Committee. FIGO staging of endometrial cancer: 2023. Int J Gynaecol Obstet. 2023 Aug;162(2):383-394. doi: 10.1002/ijgo.14923. Epub 2023 Jun 20. PMID 37337978
• Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Tr PMID 31908301
• Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: diagnosis, treatment and follow-up. Ann Oncol. 2016 Jan;27(1):16-41. doi: 10.1093/annonc/mdv484. Epub 2015 Dec 2. PMID 26634381

Идентификаторы

NCT: NCT06306170 · GYN-ART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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