Vulvacarcinoma, vulvar cancer
Conditions
Interventions
Surgical treatment consists of standard local treatment (wide local resection, vulvectomy) of the vulvar tumour combined with a uni- or bilateral SLN procedure.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible for the study (non SLN cohort and SLN cohort, group A-C):- Possible to understand and read Dutch. - Possible to understand the study and give informed consent. - No age limit specified. - Patients should mentally, physically and geographically be able to undergo follow-up. In order to be eligible to undergo the SLN procedure, a subject must meet all of the following criteria: - First local recurrent SCC of the vulva. - Previous treatment with wide local excision or (partial) vulvectomy tumours < 4 cm., not encroaching in urethra, vagina or anus with clinically negative inguinofemoral lymph nodes. - Localisation and size of the tumour are such that perilesional injection of the tracers at three or four sites is possible. - Preoperative imaging does not show enlarged (> 10 mm sort axis) or suspicious nodes. - Fit for surgery
Exclusion criteria
Exclusion criteria: Potential subject who meets any of the following criteria should not undergo the SLN procedure in the study arm (A-B), the patient can be asked for the non SLN cohort. - Inoperable tumours and tumours with diameter > 4 cm. - Patients with inguinofemoral lymph nodes at palpation clinically suspect for metastases, at radiology enlarged (> 10 mm short axis) / suspicious groin nodes and with cytological proven inguinofemoral lymph node metastases. - A history of bilateral IFL and radiotherapy to the groins. - A lateral tumour and history of ipsilateral IFL and ipsilateral radiotherapy. - Tumour encroaching urethra, vagina, or anus. - Previous surgery of the vulva was not radical (margin < 1 mm) and additional treatment (2nd surgery or radiotherapy) was not performed. - Multifocal recurrent disease of the vulva. - Synchronous, non- curable 2nd malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point is the number of groin recurrences after an SLN procedure, with a tumor negative SLN. | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of the SLN procedure, surgical drawbacks, wound healing problems, long term sequela, and quality of life in women treated for a 1st recurrent vulvar cancer. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactH.C. Doorn
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed