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NCT Number: NCT04147780

Sentinel Node Extended in Squamous Cell Vulvar Cancer

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.

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Key information

Conditions

Vulva Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sentinel Lymph Node Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska University Hospital, Stockholm, Stockholm County, Sweden

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About this study

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:

  • primary tumors ≥4cm
  • primary multifocal tumors
  • local recurrence, earlier no treatment of the groins or only sentinel node biopsy
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with squamous cell vulvar cancer and
  • primary tumors ≥ 4cm
  • multifocal primary tumors
  • local recurrence, earlier no treatment of the groins or only sentinel node biopsy
  • 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

Treatment and study plan

Sentinel node biopsy

Procedure

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

Primary outcomes

  1. Detection rate and negative predictive value for sentinel node biopsy

    Time frame: 2019-2021

    Calculated for each group separately. Per groin and per patient.

Secondary outcomes

  1. Number of retrieved sentinel lymph nodes

    Time frame: 2019-2021

    Per groin

  2. Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination

    Time frame: 2019-2021

    Per groin and per patient

Sponsors and collaborators

Lead sponsor

Diana Zach

Other

Collaborators

  • Sahlgrenska University Hospital
  • Skane University Hospital
  • University Hospital, Linkoeping

Registry information

Official study title

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

Acronym: SNEX

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 1, 2019
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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