Clinical trial NCT06314568: Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaginal Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 278
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy

Brief 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

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

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

Primary outcomes:
measure: Local Control
timeFrame: 6 months
Secondary outcomes:
measure: Cancer specific overall survival
timeFrame: 6 months
measure: Toxicities
timeFrame: 6 months
measure: Overall survivall
timeFrame: 6 months
measure: Disease free survivall
timeFrame: 6 months
measure: Metastasis free survival
timeFrame: 6 months
measure: Changes in quality of life over time
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: VALENTINA LANCELLOTTA
role: PRINCIPAL_INVESTIGATOR
References: