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

Recruiting

• Conditions: Gynecologic Cancer; Radiotherapy; Complications; Progression, Clinical; Radiotherapy Side Effect; Survivorship; Progression, Disease
• Interventions: Radiation: Image Guided Radiotherapy

• Registration Number: NCT06306170
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-02-14
• Study Start: 2024-02-15
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-19
• Last Update Posted: 2025-04-22
• Primary Completion: 2027-02-15
• Study Completion: 2029-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• other tumors
• > 90 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gynecologic cancer patients	Image Guided Radiotherapy	Gynecologic cancer patients treated with IGRT, IMRT, SBRT (advanced radiotherapy-ART)

Primary Outcome Measures

Name	Time	Method
Local Relapse Free Survival	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
Distant Metastases Free Survival	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
Disease Free Survival	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
Regional Relapse Free Survival	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
Overall Survival	From date of radiotherapy end until the date of death from any cause, assessed up to 120 months	survival from all causes
Cancer Specific Survival	From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months	cancer survival

Secondary Outcome Measures

Name	Time	Method
Late toxicity	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
Acute toxicity	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

Trial Locations

Locations (1)

San Raffaele Scientific Institute; 🇮🇹 Milan, MI, Italy