International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma.
- Who it may be relevant to
- Registry conditions: Recurent Vulvar Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sentinel Node Biopsy in Relapsed Vulvar Cancer. VULCA-NODE Study.
Overview
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
- 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. .
Primary outcome measures
- To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting. [Time frame: From enrollment to the first 30 day after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- La Paz University Hospital — Madrid
Identifiers
NCT: NCT07023601 · HULP: PI-6605