Actively Recruiting

Age: 18Years - 90Years
FEMALE
ID06306170

Efficacy of Advanced Radiotherapy in Gynecological Cancer Patients

Led by IRCCS San Raffaele · Updated on 2025-04-22

1000

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

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)

Who Can Participate

Age: 18Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Gynecologic cancer patients
  • Older than 18 years
  • Treated with advanced radiotherapy techniques such as IGRT, IMRT, or SBRT
Not Eligible

You will not qualify if you...

  • Having other types of tumors
  • Older than 90 years

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

San Raffaele Scientific Institute

Milan, MI, Italy, 20132

Actively Recruiting

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Research Team

A

Andrei Fodor, MD

N

Nadia G Di Muzio, Prof

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

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https://pubmed.ncbi.nlm.nih.gov/33538338

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...

https://pubmed.ncbi.nlm.nih.gov/31908301

Substantial lymph-vascular space invasion (LVSI) as predictor of distant relapse and poor prognosis in low-risk early-stage endometrial cancer.

Lucia Tortorella, Stefano Restaino, Gian Franco Zannoni...

https://pubmed.ncbi.nlm.nih.gov/33470061