Recruiting

Vulvar Cancer

Sponsor:

British Columbia Cancer Agency

Code:

NCT05576831

Conditions

Vulvar Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Re-excision

Study Details

Brief summary:

Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.

Conditions

Vulvar Cancer

Study ID

NCT05576831

Start date

Nov 25, 2024

Status verified date

Jan, 2026

Completion date

Nov 25, 2031

Anticipated

Primary completion date

Nov 25, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

249 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: HPV-A VSCC

Patients with HPV-A VSCC and margins that are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status) will be eligible for the de-escalation prospective study.

experimental: HPV-I VSCC

If the margins are negative for cancer but <8mm, or positive for Differentiated vulvar intraepithelial neoplasia (dVIN), and/or positive for p53 abnormality on IHC, these patients will be randomized (2:1) to further re-excision vs observation only.

Interventions

Re-excision

Re-excise (one take back only) Excise scar aiming for 1-2cm margin

Primary outcome measure

  • Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma [ Time Frame: 3 years from study enrollment ]

Central Contacts and Locations

Central contacts

Locations

BC Cancer - Vancouver Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 2E6

Contacts

Principal Investigator:

Jessica McAlpine, MD

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-02-03.