Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

Vaginal Cancer Clinical Trial

— TRIDENT  

Official title:

Radiochemotherapy Treatment Followed by Interventional Radiotherapy in Patients Affected by Vagina Carcinoma Multi-centric Prospective Observational Study Trimodal Definitive Invasive Vaginal Carcinoma Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314568
• Other study ID #: 6350
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Vaginal Cancer
• Vaginal Neoplasms

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