At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 157 target
Drug / intervention
Cisplatin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 11
- ✓Histologically confirmed primary squamous cell carcinoma of the vulva
- ✓T1 tumor not encroaching urethra, vagina, or anus
- ✓Depth of invasion greater than 1mm
- ✓Tumor diameter less than 4cm
Key exclusion· 11
- ✕Inoperable tumors or tumors larger than 4cm
- ✕Multifocal tumors
- ✕Pathology other than squamous cell carcinoma
- ✕Enlarged or suspicious lymph nodes proven metastatic by fine needle aspiration cytology
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial
In Brief
A Phase 2 clinical trial evaluating Radiotherapy combined with cisplatin and Cisplatin for Vulvar Cancer and 2 related conditions. Currently recruiting, targeting 157 participants across 27 sites in 2 countries.
Detailed Summary
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Cancer, Sentinel Lymph Node, Lymph Node Metastases
CountriesNetherlands, United States
CollaboratorsDutch Cancer Society, NRG Oncology
Timeline
Phase 2Recruiting
202120222023202420252026202720282029
Enrollment StartJan 2021
First PostedOct 2021
TodayJul 2026
Primary CompletionJan 2028
Study CompletionJan 2029
First PostedOct 13, 2021
Enrollment StartJan 1, 2021
Primary CompletionJan 1, 2028
Study CompletionJan 1, 2029
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 4.7 years agoPrimary completion in 1.5 years
Interventions
Radiotherapy combined with cisplatinradiation
Inguinofemoral radiotherapy combined with weekly cisplatin
Cisplatindrug
Inguinofemoral radiotherapy combined with weekly cisplatin