Stratifying vulvar squamous cell carcinoma by HPV and p53 to guide surgical excision

STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study

See if using HPV (p16) and p53 test results to guide how much tissue is removed during surgery helps women with early-stage vulvar squamous cell carcinoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 249 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: British Columbia Cancer Agency (other)
• Drugs / interventions: radiation
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT05576831 on ClinicalTrials.gov

What this trial studies

This prospective interventional study classifies vulvar squamous cell carcinomas by HPV (p16) and p53 status and applies predefined margin-based algorithms to direct decisions about re-excision. Patients with HPV-associated tumors may be offered less radical surgery when margins are close, while HPV-independent tumors with p53 abnormalities may be managed more aggressively to lower recurrence risk. The study records clinical outcomes and patient-reported outcomes including body image, sexual function, urinary symptoms, genital pain, and fear of recurrence. Outcomes for stratified management will be compared to standard approaches to see if changes in surgical extent improve recurrence rates and quality of life.

Who should consider this trial

Good fit: Women aged 18 or older with primary FIGO stage I–II vulvar squamous cell carcinoma who have post-surgical margins that meet the protocol's HPV/p53-based criteria are ideal candidates.

Not a fit: Patients with recurrent vulvar cancer, non-squamous histologies, or FIGO stage III–IV disease are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary wide excisions and treatment side effects for HPV-associated cases while ensuring more appropriate, potentially more aggressive treatment for high-risk HPV-independent tumors.

How similar studies have performed: Retrospective studies support differences in behavior by HPV and TP53 status, but prospective surgical management guided by p16 and p53 is relatively novel and not yet widely tested.

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
* Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
* Margin status after primary surgery:

  * HPV-I VSCC: margins are negative for cancer but \<8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
  * HPV-A VSCC: margins are negative for cancer but \<8mm (regardless of in-situ (HSIL) margin status)
* Age ≥18 years old
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.

Exclusion Criteria:

* Recurrent vulvar squamous cell carcinoma
* Non-squamous cell carcinoma histotypes
* FIGO stage III- IV disease
* Patients referred for adjuvant radiation for close margins
* Margins positive for cancer

Where this trial is running

Vancouver, British Columbia

• BC Cancer - Vancouver Centre — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Amy Jamieson, MD — BC Cancer
• Study coordinator: Amy Jamieson, MD

Conditions: Vulvar Cancer