Re-excision for Vulvar Cancer

(STRIVE Trial)

Overseen By Jessica McAlpine, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Disqualifiers: Recurrent cancer, Stage III-IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 3-4 weeks

249 Participants Needed

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).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Re-excision for Vulvar Cancer?

The study on re-excision for early-stage vulvar squamous cell carcinoma suggests that re-excision can help improve recurrence-free survival when the initial surgery leaves close or positive margins, meaning cancer cells are found at the edge of the removed tissue. ^{1 2 3 4 5}

Is re-excision for vulvar cancer generally safe for humans?

The studies reviewed do not provide specific safety data for re-excision in vulvar cancer, but a study on electrochemotherapy, another treatment for vulvar cancer, found it to be safe with no serious adverse events reported. ^{1 2 3 6 7}

How does the treatment 'Re-excision' for vulvar cancer differ from other treatments?

Re-excision for vulvar cancer is unique because it involves surgically removing additional tissue after the initial surgery if cancerous cells are found near the edges of the removed tissue. This approach is different from other treatments like radiation or chemotherapy, as it focuses on ensuring all cancerous cells are removed to prevent recurrence. ^{3 8 9 10 11}

Research Team

Amy Jamieson, MD

Principal Investigator

BC Cancer

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.

Exclusion Criteria

Margins positive for cancer

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

My condition is recurrent vulvar squamous cell carcinoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical management based on HPV and p53 stratified algorithms

3-4 weeks

1 visit (in-person) for surgery

Follow-up

Participants are monitored for recurrence and quality of life outcomes

3 years

Every 4 months for the first 3 years

Patient Reported Outcomes Assessment

Assessment of patient-reported outcomes such as quality of life and decisional conflict

1 year

Preoperatively, after surgery at 4-6 weeks, 4 months, 8 months, and 12 months

Treatment Details

Interventions

• Re-excision

Trial Overview 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.

Participant Groups

Group I: HPV-I VSCC Experimental Treatment 1 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 VSCC Active Control 1 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.

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Gynecologic Cancer Initiative

Collaborator

Trials

1

Recruited

250+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Australia New Zealand Gynaecological Oncology Group

Collaborator

Trials

16

Recruited

5,800+

Findings from Research

Perforator flaps are highlighted as a superior surgical technique for vulvar reconstruction compared to conventional flaps, enhancing the outcomes of surgery.

The reconstruction aims to restore not only the anatomy and function of the external female genitalia but also to support the patient's body image, sexual function, and essential bodily functions like urination and defecation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perforator flaps for vulvar reconstruction: basic principles. Raposio, E., Moioli, M., Raposio, G., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Role of adjuvant radiation or re-excision for early stage vulvar squamous cell carcinoma with positive or close surgical margins. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Advanced vulvar carcinoma: is it worth operating? A perioperative management protocol for radical and reconstructive surgery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Low yield of residual vulvar carcinoma and dysplasia upon re-excision for close or positive margins. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Reconstructive surgery following resection of primary vulvar cancers. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Radiotherapy as Definitive Treatment of Patients with Primary Vulvar Carcinoma Unfit for Surgery and with Recurrent Vulvar Carcinoma After Primary Radical Surgery: Results of a Retrospective Single-center Study. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Vulvar Cancer Treatment with Electrochemotherapy. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Chemoradiation with 5-fluorouracil and mitomycin C in the treatment of vulvar squamous cell carcinoma. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Recurrent vulvar cancer. [2022]

9. Singapore pubmed.ncbi.nlm.nih.gov

The surgical management of recurrent carcinoma of the vulva. [2020]

10. Italy pubmed.ncbi.nlm.nih.gov

[Reconstructive problems after radical vulvectomy in carcinoma: current trends]. [2006]

11. Italy pubmed.ncbi.nlm.nih.gov

Perforator flaps for vulvar reconstruction: basic principles. [2023]