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

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

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07023601

Acronym

VULCA-NODE

Enrollment

100

Registered

2025-06-17

Start date

2025-08-01

Completion date

2029-12-31

Last updated

2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurent Vulvar Carcinoma

Brief 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

Interventions

OTHERSentinel 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026