Clinical trial NCT04147780: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulva Cancer
Sentinel Lymph Node
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: University Hospital, Linkoeping
name: Skane University Hospital
First posted: 2019-11-01
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with primary squamous vulvar cancer with tumors ≥ 4cm or multifocal tumors, and all patients with a local recurrence after primary squamous vulvar cancer in Sweden, diagnosed during the recruitment period

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.

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

Primary outcomes:
measure: Detection rate and negative predictive value for sentinel node biopsy
timeFrame: 2019-2021
Secondary outcomes:
measure: Number of retrieved sentinel lymph nodes
timeFrame: 2019-2021
measure: Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination
timeFrame: 2019-2021
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Stockholms Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linkoping
country: Sweden
facility: Linkopings University Hospital
city: Lund
country: Sweden
facility: Skanes University Hospital Lund
Study officials:
affiliation: Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
name: Diana Zach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zach D, Kannisto P, Stenstrom Bohlin K, Moberg L, Kjolhede P. Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden. Int J Gynecol Cancer. 2020 Mar;30(3):402-405. doi: 10.1136/ijgc-2019-000938. Epub 2019 Dec 2.