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

April 19, 2025 updated by: Andrei Fodor, MD, IRCCS San Raffaele

Efficacy of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132
        • Recruiting
        • San Raffaele Scientific Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Gynecologic cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • other tumors
  • > 90 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gynecologic cancer patients
Gynecologic cancer patients treated with IGRT, IMRT, SBRT (advanced radiotherapy-ART)
Radiation: Image Guided Radiotherapy
Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated
Other Names:
  • Stereotactic Body Radiotherapy
  • Intensity Modulated Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
regional control (regional lymph nodal chain) of the disease
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
distant metastases developed after the treatment
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
absence of disease progression during the follow-up
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
survival from all causes
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
cancer survival
From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months
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)
From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Andrei Fodor, MD, IRCCS San Raffaele Scientific Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2029

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYN-ART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study (anonymized individual participant data) are available on request from the corresponding author to researchers who provide a methodologically sound proposal. Requests made to the corresponding author (AF) will be evaluated by the Lombardy Territorial Ethics Committee

IPD Sharing Time Frame

for another 2 years after the closure of the study

IPD Sharing Access Criteria

request from the corresponding author approved by the Lombardy Territorial Ethics Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gynecologic Cancer

Clinical Trials on Image Guided Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe