Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiochemotherapy plus interventional radiotherapy.
- Who it may be relevant to
- Registry conditions: Vaginal Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- 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
Primary outcome measures
- Local Control [Time frame: 6 months]
Secondary outcome measures (6)
- Cancer specific overall survival [Time frame: 6 months]
- Toxicities [Time frame: 6 months]
- Overall survivall [Time frame: 6 months]
- Disease free survivall [Time frame: 6 months]
- Metastasis free survival [Time frame: 6 months]
- Changes in quality of life over time [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Identifiers
NCT: NCT06314568 · 6350