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Recruiting NCT06306170

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

— Observational Gynecologic Cancer Radiotherapy Side Effect Radiotherapy; Complications Survivorship

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Image Guided Radiotherapy.
Who it may be relevant to
Registry conditions: Gynecologic Cancer, Radiotherapy Side Effect, Radiotherapy; Complications, Survivorship. Basic parameters: 18 years — 90 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Local Relapse Free Survival [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From date of radiotherapy end until the date of death from any cause, assessed up to 120 months]
  • Cancer Specific Survival [Time frame: From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months]
Secondary outcome measures (2)
  • Acute toxicity [Time frame: Up to three months from the start of radiotherapy]
  • Late toxicity [Time frame: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • other tumors
  • > 90 years old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • San Raffaele Scientific Institute — Milan

Publications

  • 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

Identifiers

NCT: NCT06306170 · GYN-ART

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗