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NCT Number: NCT06306170

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

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.

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Key information

Conditions

Gynecologic Cancer Disease Attributes Disease Progression Pathologic Processes Pathological Conditions, Signs and Symptoms Progression, Clinical Progression, Disease Radiation Injuries Radiotherapy Side Effect Radiotherapy; Complications Survivorship Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • other tumors
  • > 90 years old

Treatment and study plan

Image guided radiotherapy

Radiation

Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated

Other names: Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy

Primary outcomes

  1. 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

    local control (on the treated site) of the disease

  2. 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

    regional control (regional lymph nodal chain) of the disease

  3. 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

    distant metastases developed after the treatment

  4. 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

    absence of disease progression during the follow-up

  5. Overall Survival

    Time frame: From date of radiotherapy end until the date of death from any cause, assessed up to 120 months

    survival from all causes

  6. Cancer Specific Survival

    Time frame: From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months

    cancer survival

Secondary outcomes

  1. Acute toxicity

    Time frame: Up to three months from the start of radiotherapy

    Toxicity developed in the first three months after the treatment, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity

  2. 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

    Toxicity developed after three months until the end of follow-up or death, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity

Other outcomes

  1. Predictive factors for disease progression and death

    Time frame: From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months

    Factors predicting survival. Survival trees, univariate/multivariate Cox regression models will be estimated to identify potential risk factors associated with survival outcomes

  2. Radiomic predictive factors for disease progression and death

    Time frame: From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months

    CT and PET/CT radiomic features predicting relapse or death will be extracted, acording to IBSI (Image Biomarker Standardisation Initiative), owning to the different families of features: Morphology, Statistical, Intensity Histogram, Grey Level Cooccurrence Matrix 3D-average, Grey Level Co-occurrence Matrix 3D-combined, Grey Level Run Lenght 3D-average. Grey Level Run Lenght 3D_combined, Grey Level Size Zone Matrix 3D, Neighbors Grey Tone Difference Matrix 3D, Grey Level Distance Zone Matrix 3D, standard convolutional filters within radiomic workflow (wavelets, Laplacian of Gaussian)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei Fodor, MD

CONTACT

[email protected]

+390226437634

Nadia G Di Muzio, Prof

CONTACT

[email protected]

+390226437643

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: GYN-ART

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Mar 12, 2024
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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