Re-excision for Vulvar Cancer
(STRIVE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAmy Jamieson, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: British Columbia Cancer Agency

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new way to decide how much surgery women with vulvar cancer need. It aims to improve outcomes by either reducing unnecessary surgery or ensuring all cancer is removed. The study focuses on women with vulvar squamous cell carcinoma (VSCC).

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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.

My diagnosis is vulvar squamous cell carcinoma.

+2 more

Exclusion Criteria

Margins positive for cancer

My cancer is in an advanced stage (III-IV).

My condition is recurrent vulvar squamous cell carcinoma.

+2 more

Participant Groups

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.

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.