Gynecologic Cancer, Progression, Clinical, Progression, Disease, Radiotherapy; Complications, Radiotherapy Side Effect, Survivorship
Conditions
Keywords
Gynecologic Cancer, Image Guided Radiotherapy, PET/CT, Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy, Oligometastases
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.
Interventions
RADIATIONImage Guided Radiotherapy
Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Inclusion criteria
* gynecologic cancer patients * \>18 years old * treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)
Exclusion criteria
* other tumors * \> 90 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of radiotherapy end until the date of death from any cause, assessed up to 120 months | survival from all causes |
| 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 |
| 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 |
| 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 |
| Cancer Specific Survival | From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months | cancer survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Predictive factors for disease progression and death | 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 |
| Radiomic predictive factors for disease progression and death | 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) |
Countries
Italy
Contacts
Primary ContactAndrei Fodor, MD
Backup ContactNadia G Di Muzio, Prof
Outcome results
None listed