vulvar cancer
Conditions
Interventions
When definitive histopathological examination shows a SN metastasis > 2mm
and/or extracapsular extension, chemoradiation will be given: in principle only
the side with the metastatic involved side o
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histological confirmed primary SCC of the vulva - T1 tumor, not encroaching urethra/vagina/anus - Depth of invasion > 1mm - Tumor diameter 1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound) - Possibility to obtain informed consent - Metastatic sentinel lymph node; size of metastasis > 2mm - Metastatic sentinel lymph node: more than 1 SN with metastasis = 1.5 x 109 /L • Platelet count >= 100 x 109 /L • Creatinine clearance >= 40 ml/min measured by the Cockroft Gault formula • Total bilirubin = 12 weeks
Exclusion criteria
Exclusion criteria: - Inoperable tumors and tumors > 4cm - Multifocal tumors - Tumors with other pathology than squamous cell carcinoma - Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology - No other carcinomas, other than basal cell carcinomas, within last 5 years - History of pelvic radiotherapy - History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment - Pregnant female or nursing mother - Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure within 6 months before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Groin recurrence rate in the first two years after primary treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: - Treatment related morbidity (CTC AE v 4.0) - Disease-specific and overall survival - Patient-reported quality of life | — |
Countries
Netherlands
Outcome results
None listed