Clinical trial · Observational
Sentinel Node Extended in Squamous Cell Vulvar Cancer
Can the Investigators Extend the Indication for Sentinel Node Biopsy in Vulvar Cancer? A Nationwide Feasibility Study From Sweden
NCT04147780CI-TRIAL-00070964SNEXcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Vulva Cancer | Vulvar Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Primary vulvar cancer, tumor ≥ 4cm
- description
- Patients with primary squamous cell vulvar cancer, unifocal tumor ≥ 4cm: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy
- interventionNames
- Procedure: Sentinel node biopsy
- label
- Primary vulvar cancer, multifocal tumor
- description
- Patients with primary squamous cell vulvar cancer, multifocal tumor: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy
- interventionNames
- Procedure: Sentinel node biopsy
- label
- Local recurrence after vulvar cancer, no earlier treatment
- description
- Patients with a local recurrence of a primary squamous cell vulvar cancer, earlier without treatment of the groins or solely sentinel node biopsy: Sentinel node biopsy additional to radical inguinofemoral lymphadenectomy
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDZach D, Stenstrom Bohlin K, Kannisto P, Moberg L, Kjolhede P. Time to extend the indication for sentinel node biopsy in vulvar cancer? Results from a prospective nationwide Swedish study. Int J Gynecol Cancer. 2023 Dec 4;33(12):1845-1852. doi: 10.1136/ijgc-2023-004790. PMID 37918956
- DERIVEDZach 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. PMID 31796533