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

NCT05576831 | Recruiting DMC

• 1 other identifier: STRIVE
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma

  Duration of time from registration to time of recurrent disease in the vulvar

  3 years from study enrollment

Secondary Outcomes (6)

• Health Economic Impact of implementation of HPV and p53 stratified treatment algorithms - Measure the delta in surgical parameters (surgical take backs, longer hospital stay for more extensive surgery)

  through study completion, an average of 1 year

• Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.

  Preoperatively, after surgery at 4-6 weeks, 4 months, 8 months and 12 months, through study completion, an average of 1 year

• Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area

  through study completion, an average of 1 year

• Patient Decisional Conflict Scale - Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after treatment

  Preoperative

• Disease-specific survival is defined as the time from study enrolment to the time of death from vulvar cancer. Overall survival is defined as the time from study enrolment to the time of death from any cause.

  Every 4 months for first 3 years

Study Arms (2)

HPV-A VSCC

NO INTERVENTION

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.

HPV-I VSCC

EXPERIMENTAL

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.

Procedure: Re-excision

Interventions

Re-excision PROCEDURE

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

HPV-I VSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Gynecologic Cancer Initiative: collaborator
• Australia New Zealand Gynaecological Oncology Group: collaborator
• Canadian Cancer Trials Group: collaborator

Study Sites (1)

BC Cancer - Vancouver Centre

Vancouver, British Columbia, V5Z 2E6, Canada

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Amy Jamieson, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Jamieson, MD

CONTACT

604-875-4268; Amy.Jamieson@vch.ca

Jessica McAlpine, MD

CONTACT

604-875-4268; Jessica.Mcalpine@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Division Head, Gynecologic Oncology Professor, Department of Obstetrics and Gynecology Gynecologic Tissue Bank Director

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 13, 2022
• Study Start: November 25, 2024
• Primary Completion (Estimated): November 25, 2031
• Study Completion (Estimated): November 25, 2031
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CA (1)