Clinical trial · Observational
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
NCT06314568CI-TRIAL-00093717TRIDENTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiochemotherapy plus interventional radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with vaginal cancer
- description
- Patients affected by vaginal cancer
- interventionNames
- Radiation: Radiochemotherapy plus interventional radiotherapy
Primary outcomes (1)
- measure
- Local Control
- timeFrame
- 6 months
- description
- 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 (6)
- measure
- Cancer specific overall survival
- timeFrame
- 6 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.