Sentinel Node Extended in Squamous Cell Vulvar Cancer

Sentinel Lymph Node Clinical Trial

— SNEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147780
• Other study ID #: 2019-04647
• Status: Completed
• Start date: December 14, 2019
• Est. completion date: February 15, 2023

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 15, 2023
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with squamous cell vulvar cancer and

1. primary tumors = 4cm

2. multifocal primary 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

• = 18 years of age

• Considered clinically appropriate for surgery

• Informed consent

Exclusion Criteria:

• Eastern Cooperative Oncology Group performance status > 2

• Disability to read or write in Swedish

• Dementia / severe psychiatric illness leading to disability to understand the study / study information

• Signs of inguinal lymph node or distant metastases

• Ongoing pregnancy

Related Conditions & MeSH terms

• Sentinel Lymph Node
• Vulva Cancer
• Vulvar Neoplasms

Intervention

Procedure:
• Sentinel node biopsy
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Linkopings University Hospital	Linkoping
Sweden	Skanes University Hospital Lund	Lund
Sweden	Karolinska University Hospital	Stockholm	Stockholms Lan

Sponsors (4)

Lead Sponsor	Collaborator
Diana Zach	Sahlgrenska University Hospital, Sweden, Skane University Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate and negative predictive value for sentinel node biopsy	Calculated for each group separately. Per groin and per patient.	2019-2021
Secondary	Number of retrieved sentinel lymph nodes	Per groin	2019-2021
Secondary	Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination	Per groin and per patient	2019-2021