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NCT Number: NCT06314568

Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

VALENTINA LANCELLOTTA

CONTACT

[email protected]

+390630155701

VALENTINA LANCELLOTTA

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Local Control

    Time frame: 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

Secondary outcomes

  1. Cancer specific overall survival

    Time frame: 6 months

    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

  2. Toxicities

    Time frame: 6 months

    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.

  3. Overall survivall

    Time frame: 6 months

    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

  4. Disease free survivall

    Time frame: 6 months

    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

  5. Metastasis free survival

    Time frame: 6 months

    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. Changes in quality of life over time

    Time frame: 6 months

    Anova for repeated measures or the corresponding non-parametric Friedman test will be used to identify changes in quality of life over time.

Study contacts

Contact information is provided by the study sponsor or research team.

VALENTINA LANCELLOTTA, MD

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: TRIDENT

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 18, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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