Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden. Issue 3 (March 2020)

• Record Type: Journal Article
• Authors: Zach, Diana; Kannisto, Paivi; Stenström Bohlin, Katja; Moberg, Louise; Kjölhede, Preben
• Is Part Of: International journal of gynecological cancer. Volume 30:Issue 3(2020)
• Publication Date: 2020-03
• Subjects: vulvar and vaginal cancer -- sentinel lymph node; Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2019-000938
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Background: In squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences. Primary objective: This study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial. Study hypothesis: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. Trial design: This study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy. Inclusion and exclusion criteria: Inclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins. Primary endpoint: The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. Sample size: In each of the four study arms, recruitment of 20–30 patients is planned. Estimated dates for completing recruitment and presenting results: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021. Trial registration: The trial is registered at "ClinicalTrials.gov" (ID: NCT04147780).