Study of Advanced Radiotherapy Techniques in Women With Gynecologic Cancer
Evaluating Treatment Effects and Long-Term Outcomes
Led by IRCCS San Raffaele · Updated on 2025-04-22
1000
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting an observational study on patients with gynecologic cancers who have been treated with advanced radiotherapy techniques such as Image Guided Radiotherapy IGRT, Intensity Modulated Radiotherapy IMRT, and Stereotactic Body Radiotherapy SBRT. The study aims to analyze toxicity levels and clinical outcomes including tumor control and survival rates. The study includes patients treated at the IRCCS San Raffaele Scientific Institute between January 2005 and January 2024.
The study involves reviewing clinical and dosimetric data from these patients to assess acute and late treatment-related toxicities and to evaluate outcomes like local, regional, and distant control of the cancer, disease-free survival, cancer-specific survival, and overall survival. Researchers will also explore factors that may predict toxicity, disease progression, and survival, including radiomic characteristics from imaging.
Participants medical records and treatment details will be analyzed without any additional interventions. The primary measurements include survival without relapse or metastases over up to 120 months after radiotherapy completion, as well as acute toxicity within three months and late toxicity beyond three months after treatment. This long-term follow-up is intended to provide insights into the safety and effectiveness of advanced radiotherapy for gynecologic cancers.
CONDITIONS
Brief Title
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
Research Team
A
Andrei Fodor, MD
N
Nadia G Di Muzio, Prof
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Treated with advanced radiotherapy techniques such as IGRT, IMRT, or SBRT
You will not qualify if you...
Having other types of tumors
Older than 90 years
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 120 months
Participants who underwent advanced radiotherapy for gynecological cancer are observed. Clinical and dosimetric data are retrieved and analyzed to evaluate outcomes and toxicity.
Visits and assessments occur as part of routine follow-up care over several years
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
A Large, Multicenter, Retrospective Study on Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Ovarian Cancer (MITO RT1 Study): A Collaboration of MITO, AIRO GYN, and MaNGO Groups.
Gabriella Macchia, Roberta Lazzari, Nicoletta Colombo...
Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation.
Matthias Guckenberger, Yolande Lievens, Angelique B Bouma...
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Efficacy and Safety of Stereotactic Body Radiation Therapy in Oligometastatic Uterine Cancer (MITO-RT2/RAD): A Large, Real-World Study in Collaboration With Italian Association of Radiation Oncology, Multicenter Italian Trials in Ovarian Cancer, and Mario Negri Gynecologic Oncology Group Groups.