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

Launched by HOSPITAL UNIVERSITARIO LA PAZ · Jun 9, 2025

Keywords

ClinConnect Summary

The VULCA-NODE study is an international, multicenter, single-group trial that looks at how often sentinel lymph node biopsy (checking the first lymph nodes cancer would reach) successfully identifies this area in people having their first local recurrence of vulvar cancer. The study will also compare different tracers and injection patterns for locating these nodes, track any surgical complications, examine how well the lymph nodes are assessed in detail, and look at disease-free and overall survival up to 24 months after the recurrence. It is led by Hospital Universitario La Paz in Madrid, Spain, plans to enroll about 100 participants, and is currently open to eligible patients.

Who can participate is a woman 18 years or older with a first local recurrence of vulvar squamous cell carcinoma that is unifocal and 4 cm or smaller, and that does not involve the urethra, vagina, or anus or have distant or groin metastases. Exclusions include multifocal recurrent disease or prior bilateral groin lymph node removal. If enrolled, you would undergo surgery to remove the recurrent tumor plus a sentinel lymph node biopsy (performed on one side or both sides depending on tumor location) followed by removal of groin lymph nodes on both sides. The study will monitor recovery, any surgical complications, and follow-up over time to understand outcomes after the procedure.

Gender

FEMALE

Eligibility criteria

• 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.