Sentinel Node Extended in Squamous Cell Vulvar Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vulva Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Procedure: Sentinel node biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary vulvar cancer, tumor ≥ 4cm<br>Patients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy | Procedure: Sentinel node biopsy<br>* Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.<br>|
| Primary vulvar cancer, multifocal tumor<br>Patients with primary squamous cell vulvar cancer, multifocal tumor: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy | Procedure: Sentinel node biopsy<br>* Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.<br>|
| Local recurrence after vulvar cancer, no earlier treatment<br>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<br>* Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.<br>|
| Local recurrence after vulvar cancer, earlier treatment<br>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<br>* Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.<br>|

What is the study measuring?
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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 |