Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

NCT06314568 | Recruiting

• 1 other identifier: 6350
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vaginal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cancer specific overall survival

  6 months

• Toxicities

  6 months

• Overall survivall

  6 months

• Disease free survivall

  6 months

• Metastasis free survival

  6 months

Study Arms (1)

Patients with vaginal cancer

Patients affected by vaginal cancer

Radiation: Radiochemotherapy plus interventional radiotherapy

Interventions

Radiochemotherapy plus interventional radiotherapy RADIATION

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

Patients with vaginal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Vaginal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• VALENTINA LANCELLOTTA

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VALENTINA LANCELLOTTA, MD

CONTACT

+390630155701; valentina.lancellotta@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 15, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (1)