STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
ConditionVulvar Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCanadian Cancer Trials Group
About this trial
This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?
Eligibility criteria
Qualifiers
Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC)
Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines
Vulvar resection according to standard of care guidelines
Post-operative margin assessment of tumour clearance, dVIN and p53 status.
Disqualifiers
Recurrent vulvar squamous cell carcinoma
Non-squamous cell carcinoma histotypes
Participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy
Primary tumour HPV-I p53 wild-type VSCC
Trial design
Treatments tested in this trial
- Surgery
- Active Surveillance
Treatment groups
249 Participants
are divided into 3 treatment groupsSponsors and collaborators
Canadian Cancer Trials Group
Lead sponsor
Australia New Zealand Gynaecological Oncology Group
Collaborator
Source ClinicalTrials.gov