Sentinel Node Extended in Squamous Cell Vulvar Cancer (SNEX)

Diana Zach

Status: Completed

Conditions: Sentinel Lymph Node; Vulva Cancer

Treatments: Procedure: Sentinel node biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT04147780

2019-04647

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 4 patient groups

Primary vulvar cancer, tumor ≥ 4cm

Description:

Patients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy

Treatment:

Procedure: Sentinel node biopsy

Primary vulvar cancer, multifocal tumor

Description:

Patients with primary squamous cell vulvar cancer, multifocal tumor: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy

Treatment:

Procedure: Sentinel node biopsy

Local recurrence after vulvar cancer, no earlier treatment

Description:

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

Treatment:

Procedure: Sentinel node biopsy

Local recurrence after vulvar cancer, earlier treatment

Description:

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

Treatment:

Procedure: Sentinel node biopsy