Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer
Age more than18 years old
Performance status 0,1
Hystological diagnosis of squamous vaginal cancer
HPV, p16, p53 status
Age inferior 18 years old
Performance status more than 2
Previous cancer in the last ten years
Previous radiation treatment in the region of interest
Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy
Cohort
Prospective
Radiochemotherapy plus interventional radiotherapy
RadiationAll patients with vaginal cancer will undergo radiochemotherapy (45 Gy on pelvis and tumor in association with cisplatinum) plus interventional radiotherapy (28 Gy on residual disease) with exclusive intent
Local Control
Local control, the Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Cancer specific overall survival
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Toxicities
The safety and tolerability profile of the treatment will be defined by the frequency and severity of adverse reactions as well as their possible correlation with the treatment received.
Overall survivall
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Disease free survivall
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Click on the lead sponsor to view all of their trials.
