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Clinical Trials in Italy / NCT06314568
Recruiting Observational

Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

NCT06314568 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-03-15
Last updated
2025-08-15

Condition(s) studied

Vaginal Cancer

Investigational drug(s) / intervention(s)

Radiochemotherapy plus interventional radiotherapy

Radiochemotherapy plus interventional radiotherapy: 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

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06314568 on ClinicalTrials.gov ↗ ← All trials in Italy