Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Surgery

    Procedure/Surgery

    Re-excision of vulvar cancer margin

  • Active Surveillance

    Other intervention

    The investigator will follow the patient to watch for side effects and keep track of patient's health

Treatment groups

249 Participants
are divided into 3 treatment groups
Group A: Sub-Study A: Active SurveillanceActive comparator 1 intervention
Group B: Sub-Study B: Re-excisionActive comparator 1 intervention
Group C: Sub-Study B: Active SurveillanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance

Time frame
3 years

Secondary outcomes

1

HPV-I and HPV-A VSCC cohorts: Recurrence-free survival

Time frame
3 years
2

HPV-I and HPV-A VSCC cohorts: Disease-specific survival

Time frame
3 years
3

HPV-I and HPV-A VSCC cohorts: Overall-survival

Time frame
3 years
4

HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Australia New Zealand Gynaecological Oncology Group

Collaborator

Source ClinicalTrials.gov
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