International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.

Condition(s) studied

Investigational drug(s) / intervention(s)

Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma: All patients will undergo a local tumor radical excision and unilateral (if medial border \> 1 cm from midline) or bilateral (medial border \< or equal to 1 cm from midline) Sentinel Lymph Node procedure, followed by bilateral Inguinophemoral lymphadenectomy. .

Study summary

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

Eligibility

Primary outcome measure(s)

• To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting. — From enrollment to the first 30 day after surgery

Trial sites (1)

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