Sentinel Node Extended in Squamous Cell Vulvar Cancer

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Brief Title

Sentinel Node Extended in Squamous Cell Vulvar Cancer

Official Title

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

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 Type

Observational


Primary Outcome

Detection rate and negative predictive value for sentinel node biopsy

Secondary Outcome

 Number of retrieved sentinel lymph nodes

Condition

Vulva Cancer

Intervention

Sentinel node biopsy

Study Arms / Comparison 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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

December 14, 2019

Completion Date

December 31, 2021

Primary Completion Date

October 31, 2021

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Diana Zach, MD, +46851775922, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04147780

Organization ID

2019-04647


Responsible Party

Sponsor-Investigator

Study Sponsor

Diana Zach

Collaborators

 Sahlgrenska University Hospital, Sweden

Study Sponsor

Diana Zach, MD, Principal Investigator, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden


Verification Date

February 2020