Sentinel Node Extended in Squamous Cell Vulvar Cancer

Learn more about:
Related Clinical Trial
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study Education, Immigration and HPV Vaccination: an Informational Randomized Trial Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Serial MRI Scans During Radiation Therapy A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Cisplatin+Pembrolizumab+RT in Vulvar Cancer Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery MR-HIFU for Recurrent Gynaecological Cancer Pelvic Floor Disorders in Survivors of Gynecologic Malignancies Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Validation of a Nutrition Screening Tool A Survivorship Care Plan for Gynaecological Cancer Patients Self-Advocacy Serious Game in Advanced Cancer Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) Chemoradiation-Induced Nausea and Emesis: Quality of Life A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021) A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies ChemoFx® PRO – A Post-Market Data Collection Study Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life The Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology Study Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Image-Guided Gynecologic Brachytherapy Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer Topical Imiquimod in Treating Patients With Recurrent Paget’s Disease of the Vulva Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. The Impact of the “WOMAN-PRO II Program” on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence CaptHPV : Validation of the Method “CaptHPV” for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers Effectiveness of an Individualized Symptom Education Program (ISEP) A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stage IV Vulvar Cancer Undergoing Surgery and Lymphadenectomy Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer OCT-AF Imaging of Pre-cancers of Vulva and Cervix Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer Sentinel Node Extended in Squamous Cell Vulvar Cancer Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

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


      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.


      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

      It is estimated to include 20-30 patients in each study group during a time frame of about 24


      Results are to be expected in the end of 2021.

Study Type


Primary Outcome

Detection rate and negative predictive value for sentinel node biopsy

Secondary Outcome

 Number of retrieved sentinel lymph nodes


Vulva Cancer


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


* 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


Estimated Enrollment


Start Date

December 14, 2019

Completion Date

July 31, 2022

Primary Completion Date

May 31, 2022

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




18 Years - N/A

Accepts Healthy Volunteers



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

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Diana Zach


 Sahlgrenska University Hospital, Sweden

Study Sponsor

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

Verification Date

August 2021