International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2019
Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Zach Diana, Kannisto Paivi, Stenström Bohlin Katja, Moberg Louise, Kjölhede Preben
Аннотация
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).
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).