NCT04147780

Sentinel Node Extended in Squamous Cell Vulvar Cancer

Can the Investigators Extend the Indication for Sentinel Node Biopsy in Vulvar Cancer? A Nationwide Feasibility Study From Sweden

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Diana Zach · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

Detailed description

PRIMARY OBJECTIVES: This study is primarily a pilot and feasibility trial, aiming to evaluate if sentinel node biopsy has a satisfactory detection rate and negative predictive value in certain groups of vulvar cancer patients. OUTLINE: The study is planned as a prospective, multi-center cohort study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm. Eligible patients will undergo a sentinel node biopsy additionally to their radical inguinofemoral lymphadenectomy and detection rate and negative predictive value for the sentinel procedure will be calculated. The study will consist of four patient groups: Patients with squamous cell vulvar cancer and: 1. primary tumors ≥4cm 2. primary multifocal tumors 3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy 4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy It is estimated to include 20-30 patients in each study group during a time frame of about 24 months. RESULTS: Results are to be expected in the end of 2021.

Conditions

• Vulva Cancer
• Sentinel Lymph Node

Interventions

Type	Name	Description
PROCEDURE	Sentinel node biopsy	Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.

Timeline

• Start date: 2019-12-14
• Primary completion: 2022-12-14
• Completion: 2023-02-15
• First posted: 2019-11-01
• Last updated: 2023-11-01

Locations

4 sites across 1 country: Sweden