Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer (TRIDENT)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Vaginal Cancer

Treatments

Radiation: Radiochemotherapy plus interventional radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT06314568

6350

Details and patient eligibility

About

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

Full 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

Enrollment

278 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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