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Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer | Clinical Trials | Clareo Health

RECRUITING

Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

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

NCT06314568•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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

Detailed 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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Key Dates

Start Date

March 15, 2024

Primary Completion Date

March 31, 2026

Completion Date

December 31, 2028

Last Updated

August 15, 2025

Enrollment

278

ESTIMATED participants

Conditions

Vaginal Cancer

Interventions

Radiochemotherapy plus interventional radiotherapy

RADIATION

Contacts

VALENTINA LANCELLOTTA, MD

CONTACT

+390630155701 valentina.lancellotta@policlinicogemelli.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

Inclusion Criteria

Exclusion Criteria

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