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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
278 participants
Mar 15, 2024
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria7
- 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 Criteria8
- 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
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06314568