Sentinel Node Extended in Squamous Cell Vulvar Cancer

Completed

• Conditions: Sentinel Lymph Node; Vulva Cancer

• Registration Number: NCT04147780
• Lead Sponsor: Diana Zach

Brief 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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-01
• Study Start: 2019-12-14
• Primary Completion: 2022-12-14
• Study Completion: 2023-02-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection rate and negative predictive value for sentinel node biopsy	2019-2021	Calculated for each group separately. Per groin and per patient.

Secondary Outcome Measures

Name	Time	Method
Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination	2019-2021	Per groin and per patient
Number of retrieved sentinel lymph nodes	2019-2021	Per groin

Trial Locations

Locations (4)

Karolinska University Hospital; 🇸🇪 Stockholm, Stockholms Lan, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Linkopings University Hospital; 🇸🇪 Linkoping, Sweden

Skanes University Hospital Lund; 🇸🇪 Lund, Sweden