Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer

• Radiochemotherapy plus interventional radiotherapy (Radiation): All 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

Primary outcomes

• Local Control [6 months]: 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

Secondary outcomes

• Cancer specific overall survival [6 months]: 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 [6 months]: 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 [6 months]: 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 [6 months]: 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
• Metastasis free survival [6 months]: 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
• Changes in quality of life over time [6 months]: Anova for repeated measures or the corresponding non-parametric Friedman test will be used to identify changes in quality of life over time.

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Age more than18 years old
* Performance status 0,1
* Hystological diagnosis of squamous vaginal cancer
* HPV, p16, p53 status
* Stage I, II, III and IV (AJCC 2018th version)
* Stadiation with magnetic resonance and positron emission tomography
* Informed consensus

Exclusion Criteria:

* 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
* Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
* Presence of internal pathologies that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
* Presence of distant metastases in sites other than the pelvic lymph nodes
* Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study

• VALENTINA LANCELLOTTA, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS