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

Enrolling by Invitation

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Key information

Conditions

Recurent Vulvar Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

La Paz University Hospital

Madrid, 28046, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma

Other

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. .

Primary outcomes

To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.

Time frame: From enrollment to the first 30 day after surgery

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

Sentinel Node Biopsy in Relapsed Vulvar Cancer. VULCA-NODE Study.

Acronym: VULCA-NODE

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2029
First posted: Jun 17, 2025
Registry last updated: Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.