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

NCT07023601 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-17

No results posted yet for this 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

Conditions

  • Recurent Vulvar Carcinoma

Interventions

OTHER

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. .

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023601 on ClinicalTrials.gov