ENROLLING BY INVITATION
NCT07023601
International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.
Acronym: VULCA-NODE Study Title: Sentinel Node Biopsy in Relapsed Vulvar Cancer Primary Objetive: To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.
Secondary Objetives:
* To compare the utility of different tracers in the detection of SLN for recurrent disease and the injection pattern.
* To evaluate the surgical complications rate.
* To analyze the nodal status by ultrastaging .
* To assess the disease free and overall survival at 24 months from the first recurrence, as well as the dissemination pattern after the procedure.
Study Design: International prospective multicentre study
Inclusion Criteria:
* First local recurrent squamous cell carcinoma of the vulva (SCC).
* Unifocal, smaller or equal than 4 cm vulvar tumor not involving urethra, vagina or anus.
* No distant or groin metastasis.
* To be able to understand the study and sign informed consent.
* Over 18 years old.
* To be able to undergo planned follow up.
Exclusion Criteria:
* Multifocal recurrent disease of the vulva.
* Previous bilateral IFL.
* Synchronous, non-curable second malignancy. Timing: 4 years
Gender: FEMALE
Ages: 18 Years - Any
Recurent Vulvar Carcinoma
