Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

Fondazione Policlinico Universitario Agostino Gemelli IRCCS278 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

278

Conditions

Vaginal Cancer

Interventions

Radiochemotherapy plus interventional radiotherapyRADIATION

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 6 months

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.

Time frame: 6 months

Overall survivall

Time frame: 6 months

Disease free survivall

Time frame: 6 months

Metastasis free survival

Time frame: 6 months

Central Contacts

VALENTINA LANCELLOTTA, MD

CONTACT

+390630155701 valentina.lancellotta@policlinicogemelli.it

Data from ClinicalTrials.gov

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