Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Medical Center Groningen
About this trial
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Eligibility criteria
Qualifiers
Histological confirmed primary SCC of the vulva
T1 tumor, not encroaching urethra/vagina/anus
Depth of invasion > 1mm
Tumor diameter < 4cm
Disqualifiers
Inoperable tumors and tumors > 4cm
Multifocal tumors
Tumors with other pathology than squamous cell carcinoma
Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
Trial design
Treatments tested in this trial
- Radiotherapy combined with cisplatin
- Cisplatin
Treatment groups
157 Participants
are divided into 1 treatment groupLocations
27Netherlands
Catharina Hospital Eindhoven5623EJ, Eindhoven Netherlands
University Medical Center Groningen9712RB, Groningen Netherlands
Leiden University Medical Center2333ZA, Leiden Netherlands
Radboud University Medical Center6525GA, Nijmegen Netherlands
Sponsors and collaborators
University Medical Center Groningen
Lead sponsor
Dutch Cancer Society
Collaborator
NRG Oncology
Collaborator
Source ClinicalTrials.gov