Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden
(2019) In International Journal of Gynecological Cancer- 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... (More)
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.
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- author
- Zach, Diana ; Kannisto, Paivi LU ; Stenström Bohlin, Katja ; Moberg, Louise LU and Kjölhede, Preben
- organization
- publishing date
- 2019-12-02
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- sentinel lymph node, vulvar and vaginal cancer
- in
- International Journal of Gynecological Cancer
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85076047454
- pmid:31796533
- ISSN
- 1048-891X
- DOI
- 10.1136/ijgc-2019-000938
- language
- English
- LU publication?
- yes
- id
- 32eb3054-936c-4caf-a07f-25bce3f5b3c1
- date added to LUP
- 2020-01-02 12:30:52
- date last changed
- 2023-11-19 21:18:54
@article{32eb3054-936c-4caf-a07f-25bce3f5b3c1,
abstract = {{<p>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.</p>}},
author = {{Zach, Diana and Kannisto, Paivi and Stenström Bohlin, Katja and Moberg, Louise and Kjölhede, Preben}},
issn = {{1048-891X}},
keywords = {{sentinel lymph node; vulvar and vaginal cancer}},
language = {{eng}},
month = {{12}},
publisher = {{BMJ Publishing Group}},
series = {{International Journal of Gynecological Cancer}},
title = {{Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden}},
url = {{http://dx.doi.org/10.1136/ijgc-2019-000938}},
doi = {{10.1136/ijgc-2019-000938}},
year = {{2019}},
}