Sentinel Node Extended in Squamous Cell Vulvar Cancer (SNEX)

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

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.

Study Overview

• Status: Completed
• Conditions: Sentinel Lymph Node; Vulva Cancer
• Intervention / Treatment: Procedure: Sentinel node biopsy

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 Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Linkoping, Sweden
    • Linköpings University Hospital
  • Lund, Sweden
    • Skånes University Hospital Lund
  • Stockholms Lan
    • Stockholm, Stockholms Lan, Sweden, 17776
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients with primary squamous vulvar cancer with tumors ≥ 4cm or multifocal tumors, and all patients with a local recurrence after primary squamous vulvar cancer in Sweden, diagnosed during the recruitment period

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary vulvar cancer, tumor ≥ 4cm; Patients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy	Procedure: Sentinel node biopsy; Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Primary vulvar cancer, multifocal tumor; Patients with primary squamous cell vulvar cancer, multifocal tumor: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy	Procedure: Sentinel node biopsy; Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Local recurrence after vulvar cancer, no earlier treatment; Patients with a local recurrence of a primary squamous cell vulvar cancer, earlier without treatment of the groins or solely sentinel node biopsy: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy	Procedure: Sentinel node biopsy; Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Local recurrence after vulvar cancer, earlier treatment; Patients with a local recurrence of a primary squamous cell vulvar cancer, earlier treatment of the groins by lymphadenectomy and / or (chemo-)radiation: Sentinel node biopsy if detectable, otherwise no groin treatment	Procedure: Sentinel node biopsy; Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate and negative predictive value for sentinel node biopsy	Calculated for each group separately. Per groin and per patient.	2019-2021

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diana Zach
• Collaborators: Sahlgrenska University Hospital, Sweden; University Hospital, Linkoeping; Skane University Hospital
• Investigators: Principal Investigator: Diana Zach, MD, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden

Publications and helpful links

General Publications

• Zach D, Kannisto P, Stenstrom Bohlin K, Moberg L, Kjolhede P. Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden. Int J Gynecol Cancer. 2020 Mar;30(3):402-405. doi: 10.1136/ijgc-2019-000938. Epub 2019 Dec 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2019
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Neoplasms
• Other Study ID Numbers: 2019-04647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be available.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Data excess requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No