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 groupsLocations
11Canada
BCCA - KelownaV1Y 5L3, KelownaBritish Columbia, Canada
BCCA - VancouverV5Z 4E6, VancouverBritish Columbia, Canada
Juravinski Cancer Centre at Hamilton Health SciencesL8V 5C2, HamiltonOntario, Canada
Odette Cancer CentreM4N 3M5, TorontoOntario, Canada
Sponsors and collaborators
Canadian Cancer Trials Group
Lead sponsor
Australia New Zealand Gynaecological Oncology Group
Collaborator
Source ClinicalTrials.gov