What is the mechanism of action of this treatment?

The most common treatments for Vulvar Cancer include surgical excision, radiation therapy, and chemotherapy. Surgical excision aims to remove the cancerous tissue, which is crucial for localized control of the disease. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, often used post-surgery to eliminate residual disease. Chemotherapy involves the use of drugs to destroy cancer cells, typically employed in advanced cases. Personalized surgical therapy, as studied in trials focusing on HPV and TP53 status, matters because it allows for tailored treatment plans. HPV-associated cancers may respond differently to treatments compared to HPV-independent cancers, particularly those with TP53 mutations, which are often more aggressive. This personalized approach aims to improve outcomes by optimizing treatment efficacy and minimizing overtreatment or undertreatment.

What side effects are associated with this type of intervention?

The most common treatments for vulvar cancer include surgical interventions such as wide local excision, partial vulvectomy, and laser ablation. These procedures can lead to side effects like pain, infection, scarring, and changes in vulvar anatomy, which may affect sexual function and quality of life. Radiation therapy, often used in conjunction with surgery, can cause skin irritation, fatigue, and long-term effects such as vaginal dryness and fibrosis. Chemotherapy, though less common, can lead to systemic side effects including nausea, vomiting, and increased risk of infection. Personalized surgical approaches based on HPV and TP53 status aim to minimize these side effects by tailoring the treatment to the individual patient's disease characteristics.

What prior FDA approvals exist?

There are no specific FDA approvals for treatments that tailor surgical approaches based on HPV and TP53 status in vulvar cancer. However, the general management of vulvar cancer often involves surgery, radiation, and chemotherapy. Treatments targeting HPV-related pathways, such as the use of HPV vaccines for prevention, and therapies targeting TP53 mutations, are areas of ongoing research. Personalized surgical therapy based on HPV and TP53 status aims to improve outcomes by customizing treatment to the biological characteristics of the tumor, but this approach is still under investigation and not yet part of standard FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to personalized surgical therapy for vulvar cancer patients include: 1) Targeted therapies such as those focusing on specific genetic mutations or pathways involved in cancer progression. 2) Immunotherapies, including checkpoint inhibitors and therapeutic vaccines, which aim to enhance the body's immune response against cancer cells. 3) Advanced radiation techniques like intensity-modulated radiation therapy (IMRT) and brachytherapy, which offer precise targeting of tumors while sparing healthy tissue. 4) Minimally invasive surgical techniques, including robotic-assisted surgery, which may reduce recovery time and surgical morbidity.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from study enrollment

Awards & highlights

No Placebo-Only Group

Summary

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).

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from study enrollment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Vulvar Cancer include surgical excision, radiation therapy, and chemotherapy. Surgical excision aims to remove the cancerous tissue, which is crucial for localized control of the disease. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, often used post-surgery to eliminate residual disease. Chemotherapy involves the use of drugs to destroy cancer cells, typically employed in advanced cases. Personalized surgical therapy, as studied in trials focusing on HPV and TP53 status, matters because it allows for tailored treatment plans. HPV-associated cancers may respond differently to treatments compared to HPV-independent cancers, particularly those with TP53 mutations, which are often more aggressive. This personalized approach aims to improve outcomes by optimizing treatment efficacy and minimizing overtreatment or undertreatment.