Vulvar cancer Sentinel node procedure Lymph node metastasis Vulvacarcinoom Schildwachtklierprocedure Lymfogene metastasen
Conditions
Interventions
Patients will be treated with chemoradiation, in a total dose of 56Gy to the involved site, combined with weekly cisplatin 40mg/m2
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 and / or extracapsular extension, or - Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm - Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures - Adequate bone marrow, renal and liver function: • Absolute neutrophil count ≥ 1.5 x 109 /L • Platelet count ≥ 100 x 109 /L • Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula • Total bilirubin < 1.25 x ULN • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN - Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A) - Age 18 years or older - Life expectancy of ≥ 12 weeks - Written informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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 - Desire to become pregnant - Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids - Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Groin recurrence rate in the first two years after primary treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Treatment related morbidity (CTC AE v 4.0) - Disease-specific survival - Patient-reported quality of life | — |
Contacts
Public ContactMaaike Oonk
University Medical Center Groningen, The Netherlands
Outcome results
None listed