STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision (STRIVE)

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

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?

Study Overview

• Status: Recruiting
• Conditions: Vulvar Squamous Cell Carcinoma
• Intervention / Treatment: Other: Active Surveillance; Procedure: Surgery

Detailed Description

This study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. The usual approach is defined as care most people get for early-stage vulvar cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended.

For patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).

• Study Type: Interventional
• Enrollment (Estimated): 249
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Parulekar; Phone Number: 613-533-6430; Email: wparulekar@ctg.queensu.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Recruiting
      • BCCA - Kelowna
      • Contact: Joni Kooy; Phone Number: 250 712-3900
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • BCCA - Vancouver
      • Contact: Amy Jamieson; Phone Number: 604 729-1258
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre at Hamilton Health Sciences
      • Contact: Julie My Van Nguyen; Phone Number: 905 387-9495
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network
      • Contact: Stephane Laframboise; Phone Number: 2254 416 946-4501
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Odette Cancer Centre
      • Contact: Lilian Gien; Phone Number: 416 480-4329
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • CHUM-Centre Hospitalier de l'Universite de Montreal
      • Contact: Annick Pina; Phone Number: 514 890-8444
    • Montreal, Quebec, Canada, H3T 1E2
      • Not yet recruiting
      • The Jewish General Hospital
      • Contact: Susie K.S. Lau; Phone Number: 3114 514 340-8222
    • Québec, Quebec, Canada, G1R 2J6
      • Recruiting
      • Hotel-Dieu de Quebec
      • Contact: Marie Plante; Phone Number: 418 691-5392
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • CIUSSS de l'Estrie - Centre hospitalier
      • Contact: Paul Bessette; Phone Number: 13120 819 346-1110
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Recruiting
      • Allan Blair Cancer Centre
      • Contact: Genevieve MacAulay Vacheresse
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
    • Contact: Lois Eva; Phone Number: 649 307-4949

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Participants' age must be ≥ 18 years old
• Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French
• Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements

Exclusion Criteria:

• 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
• Surgical margins positive for invasive cancer.
• Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
• Lymph node positive VSCC or lymph nodes with isolated tumour cells.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sub-Study A: Active Surveillance; If the laboratory test results show vulvar cancer is caused by HPV	Other: Active Surveillance; The investigator will follow the patient to watch for side effects and keep track of patient's health
Active Comparator: Sub-Study B: Re-excision; If the laboratory test results show vulvar cancer is not caused by HPV	Procedure: Surgery; Re-excision of vulvar cancer margin
Active Comparator: Sub-Study B: Active Surveillance; If the laboratory test results show vulvar cancer is not caused by HPV	Other: Active Surveillance; The investigator will follow the patient to watch for side effects and keep track of patient's health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
HPV-I and HPV-A VSCC cohorts: Recurrence-free survival	3 years
HPV-I and HPV-A VSCC cohorts: Disease-specific survival	3 years
HPV-I and HPV-A VSCC cohorts: Overall-survival	3 years
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	3 years
HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30	3 years
HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34	3 years
HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale	3 years
HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn	3 years

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Collaborators: Australia New Zealand Gynaecological Oncology Group
• Investigators: Study Chair: Amy Jamieson, University of British Columbia, Vancouver, BC, Canada; Study Chair: Jessica McAlpine, BCCA-Vancouver Cancer Centre, Vancouver, BC Canada

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): November 30, 2031

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Surgical Procedures, Operative; Watchful Waiting
• Other Study ID Numbers: VU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No