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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06314568
Other study ID # 6350
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2024
Est. completion date December 31, 2028

Study information

Verified date March 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact VALENTINA LANCELLOTTA, MD
Phone +390630155701
Email valentina.lancellotta@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 278
Est. completion date December 31, 2028
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
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

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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 6 months
Secondary 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. 6 months
Secondary 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 6 months
Secondary 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 6 months
Secondary Metastasis free 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 6 months
Secondary Changes in quality of life over time Anova for repeated measures or the corresponding non-parametric Friedman test will be used to identify changes in quality of life over time. 6 months
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