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.
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
1,000
Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated
San Raffaele Scientific Institute
Milan, MI, Italy
RECRUITINGLocal Relapse Free Survival
local control (on the treated site) of the disease
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 Relapse Free Survival
regional control (regional lymph nodal chain) of the disease
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 Free Survival
distant metastases developed after the treatment
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
Disease Free Survival
absence of disease progression during the follow-up
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
Overall Survival
survival from all causes
Time frame: From date of radiotherapy end until the date of death from any cause, assessed up to 120 months
Cancer Specific Survival
cancer survival
Time frame: From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
Acute toxicity
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
Time frame: Up to three months from the start of radiotherapy
Late toxicity
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
Time frame: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
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