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 groupSponsors and collaborators
University Medical Center Groningen
Lead sponsor
Dutch Cancer Society
Collaborator
NRG Oncology
Collaborator
Source ClinicalTrials.gov