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Re-excision for Vulvar Cancer (STRIVE Trial)

N/A
Waitlist Available
Led By Amy Jamieson, MD
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from study enrollment
Awards & highlights

STRIVE Trial Summary

This trial explores ways to better treat vulvar cancer, a type of cancer affecting older women and often neglected in research. Treatments may be personalized based on HPV and TP53 status to improve outcomes.

Who is the study for?
This trial is for women over 18 with early-stage vulvar cancer (stages I-II) that's not spread and has specific characteristics like being HPV-related or having certain protein mutations. Patients must consent to participate and haven't had previous vulvar cancer treatments.Check my eligibility
What is being tested?
The study tests personalized surgical treatment based on the patient's HPV status and TP53 gene changes, aiming to tailor surgery more precisely rather than using a one-size-fits-all approach for all women with this type of cancer.See study design
What are the potential side effects?
Since the intervention involves re-excision surgery, potential side effects may include typical surgical risks such as pain, infection at the incision site, bleeding, scarring, and possible complications related to anesthesia.

STRIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is vulvar squamous cell carcinoma.
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My gynecological cancer is in an early stage (I or II).

STRIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years from study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma
Secondary outcome measures
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.
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)
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
+3 more

STRIVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HPV-I VSCCExperimental Treatment1 Intervention
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.
Group II: HPV-A VSCCActive Control1 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.

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,262 Total Patients Enrolled
Gynecologic Cancer InitiativeOTHER
Australia New Zealand Gynaecological Oncology GroupOTHER
12 Previous Clinical Trials
3,934 Total Patients Enrolled

Media Library

Re-excision Clinical Trial Eligibility Overview. Trial Name: NCT05576831 — N/A
Vulvar Cancer Research Study Groups: HPV-I VSCC, HPV-A VSCC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you update me on the enrollment status of this clinical trial?

"According to the most recent update recorded on clinicaltrials.gov, this research initiative is no longer seeking applicants since it was first posted in January of 2023 and last updated in October of 2022. Nevertheless, there are 665 other trials that are presently enrolling volunteers."

Answered by AI
~166 spots leftby Dec 2025