RecruitingNCT06314568

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

278 participants

Start Date

Mar 15, 2024

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

RADIATIONRadiochemotherapy 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


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

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NCT06314568


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