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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method for vulvar cancer, which affects the outer part of the female genitalia. The researchers aim to determine if tailoring surgery based on HPV linkage and specific genetic changes can improve outcomes. Participants will either undergo another surgery (re-excision) or be closely monitored to identify the most effective approach. Women with vulvar squamous cell carcinoma who have undergone surgery but still have certain cancer margins may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that may enhance future treatment strategies.

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 prior data suggests that re-excision is safe for vulvar cancer patients?

Research has shown that re-excision, a follow-up surgery to remove additional tissue after the initial cancer surgery, is generally safe for treating vulvar squamous cell carcinoma (VSCC). One study on early-stage VSCC found that re-excision reduced the likelihood of cancer recurrence, improving recurrence-free survival.

Safety reports indicate that patients generally tolerate re-excision well. While all surgeries carry some risks, re-excision for vulvar cancer rarely causes severe side effects. Most patients recover well after the procedure, making re-excision a promising option for those with vulvar cancer, especially when the initial surgery does not remove all the affected tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about re-excision for vulvar cancer because it offers a more personalized approach to treatment. Unlike standard treatments that often involve extensive surgery, this method considers the precise characteristics of the cancer margins. By focusing on re-excising only when margins are less than 8mm or show specific abnormalities, it aims to reduce unnecessary surgeries and side effects. This tailored strategy could improve patient outcomes and quality of life by minimizing overtreatment.

What evidence suggests that re-excision might be an effective treatment for vulvar cancer?

Research has shown that vulvar squamous cell carcinoma (VSCC) can develop in different ways. One way links to the human papillomavirus (HPV), while another relates to long-term skin conditions. These differences affect cancer behavior and treatment response. In this trial, participants with HPV-associated VSCC (HPV-A VSCC) will be observed if their surgical margins are negative for cancer but less than 8mm. Participants with HPV-independent VSCC (HPV-I VSCC) will be randomized to either undergo further re-excision or observation only if their margins are negative for cancer but less than 8mm, or positive for differentiated vulvar intraepithelial neoplasia (dVIN) or p53 abnormality. Studies suggest that additional surgery to remove more tissue may not improve survival rates in early-stage VSCC. For HPV-associated VSCC, outcomes are generally positive, and it responds well to radiation. However, for VSCC not linked to HPV, especially with TP53 gene mutations, the disease can be more aggressive. This suggests that tailoring treatment based on HPV and TP53 status might improve patient outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Amy Jamieson, MD

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

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

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.

My gynecological cancer is in an early stage (I or II).

Exclusion Criteria

Margins positive for cancer

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

My condition is recurrent vulvar squamous cell carcinoma.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6693939/

Role of adjuvant radiation or re-excision for early stage ... Our results indicate that re-excision and radiation do not improve recurrence-free survival or overall survival in stage I vulvar squamous cell carcinoma with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1040842816301639

Risk factors and treatment for recurrent vulvar squamous ... In general, 5-year survival for recurrent VSCC is reported to be 25–50% compared to 50–90% for patients with primary VSCC (Guideline vulvar cancer, national ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12267115/

Prognostic Factors for Vulvar Cancer Undergoing Primary ... In this study, we evaluated clinical outcomes in women undergoing primary surgery for operable vulvar squamous cell carcinoma (SCC) to identify ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS5637

Stratification of vulvar squamous cell carcinoma (VSCC) by ... The optimal approach to margin re-excision may depend on molecular subtype. HPV associated (HPV-A) VSCC has a good outcome and is radiosensitive ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70014?af=R

Comprehensive management of vulvovaginal cancers Unfortunately, systemic treatments for recurrent or metastatic disease are limited, with 5-year survival rates at approximately 20%. Current ...

6. jnccn.org jnccn.org/view/journals/jnccn/22/2/article-p117.xml?print

Vulvar Cancer, Version 3.2024, NCCN Clinical Practice ... In a long-term efficacy and safety analysis in 121 patients at median follow-up of 25.8 months, 61% reported complete or partial responses, and median duration ...

7. withpower.com withpower.com/trial/phase-carcinoma-squamous-cell-2023-88d44

Re-excision for Vulvar Cancer (STRIVE Trial) 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 ...