Surgery and Surveillance for Vulvar Cancer

(STRIVE Trial)

Recruiting at 8 trial locations

Overseen By Wendy Parulekar

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Must not be taking: Radiation, Chemotherapy

Disqualifiers: Recurrent VSCC, Non-squamous histotypes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

249 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early-stage vulvar cancer requires more or less treatment than usual. It focuses on vulvar squamous cell carcinoma, a type of skin cancer on the vulva, and involves excision surgery to remove the affected tissue. The study includes different groups based on whether the cancer is linked to HPV, a common virus, or not. Individuals with early-stage vulvar cancer who have undergone surgery might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to important research that could refine treatment approaches for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that excision, which involves surgically removing tissue, is a common and trusted treatment for vulvar cancer. Studies confirm its safe use in treating primary vulvar cancer by removing cancerous tissue.

One study found that about 17.6% of patients experienced complications at the surgery site, a rate similar to other surgeries. These complications are usually manageable. Although randomized trials have not directly compared different surgical techniques, the results for excision appear similar to other methods, indicating it is a safe option.

Overall, excision is a standard treatment with well-known safety outcomes, making it a reliable choice for many patients with vulvar cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more tailored approach to treating vulvar cancer, focusing on active surveillance and re-excision based on the cancer's HPV status. Unlike standard treatments that often involve immediate and possibly extensive surgery, this approach allows for more personalized care. By identifying whether the cancer is HPV-related or not, the trial aims to determine if less invasive monitoring or targeted re-excision can be just as effective, potentially reducing unnecessary procedures and improving patient outcomes. This could lead to a significant shift in how vulvar cancer is managed, offering hope for less aggressive treatment strategies.

What evidence suggests that this trial's treatments could be effective for vulvar cancer?

Research has shown that removing tissue through surgery, known as excision, effectively treats early-stage vulvar cancer. Studies have found that radical local excision can result in a 5-year survival rate of 60-70%. This method is as effective as a more extensive surgery called radical vulvectomy but may have fewer side effects. Excision aims to remove the cancerous tissue while preserving as much healthy tissue as possible, making it a preferred choice for treating localized vulvar cancer. In this trial, some participants will undergo excision, while others will be part of active surveillance arms, depending on whether HPV causes their vulvar cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica McAlpine

Principal Investigator

BCCA-Vancouver Cancer Centre, Vancouver, BC Canada

Amy Jamieson

Principal Investigator

University of British Columbia, Vancouver, BC, Canada

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage vulvar squamous cell carcinoma (VSCC), staged I-II as per FIGO guidelines. Participants must have had surgery according to standard care, with post-op assessment of tumor clearance and p53 status. They should be fluent in English or French to complete questionnaires.

Inclusion Criteria

Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements

My diagnosis is vulvar squamous cell carcinoma.

I have had or will have surgery on my vulva following recommended guidelines.

Exclusion Criteria

My condition is recurrent vulvar squamous cell carcinoma.

My cancer is not squamous cell carcinoma.

My primary tumor is HPV-related and has a normal p53.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laboratory testing to determine HPV status and are assigned to sub-study A or B based on results

4-6 weeks

Sub-study A: Observation

Participants with HPV-positive cancer undergo observation without additional surgery

8 weeks

Sub-study B: Re-excision or Observation

Participants with HPV-negative cancer may undergo a second surgery or observation

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Surveillance
• Excision

Trial Overview

The study aims to determine if certain types of early-stage vulvar cancer can be treated differently than the usual approach. It involves comparing outcomes between patients undergoing surgery and those on active surveillance.

How Is the Trial Designed?

Group I: Sub-Study B: Active Surveillance Active Control 1 Intervention

If the laboratory test results show vulvar cancer is not caused by HPV

Group II: Sub-Study A: Active Surveillance Active Control 1 Intervention

If the laboratory test results show vulvar cancer is caused by HPV

Group III: Sub-Study B: Re-excision Active Control 1 Intervention

If the laboratory test results show vulvar cancer is not caused by HPV

Excision is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Excision for:

• Vulvar cancer
• Vulvar intraepithelial neoplasia (VIN)

Approved in United States as Excision for:

• Vulvar cancer
• Vulvar intraepithelial neoplasia (VIN)

Approved in Canada as Excision for:

• Vulvar cancer
• Vulvar intraepithelial neoplasia (VIN)

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Australia New Zealand Gynaecological Oncology Group

Collaborator

Trials

16

Recruited

5,800+

Published Research Related to This Trial

Wide local excision is preferred over radical vulvectomy for small tumors (T < 2 cm), and sentinel lymph node biopsy is a safe alternative that reduces unnecessary groin dissections for tumors up to 4 cm, based on a review of 1114 patients.

Pre-operative chemoradiotherapy can shrink tumors and improve surgical outcomes for inoperable cases, but it comes with significant side effects, highlighting the need for careful consideration of treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vulvar cancer: initial management and systematic review of literature on currently applied treatment approaches. Sznurkowski, JJ.[2018]

In a study of 225 patients with primary squamous cell cancer of the vulva, modified radical vulvar surgery showed similar 5-year overall survival (76.1%) and disease-free survival (83.4%) rates compared to radical surgery, indicating comparable efficacy.

Patients who underwent radical vulvar surgery experienced more surgical complications than those who had modified radical surgery, suggesting that modified radical surgery may be a safer option with fewer adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary squamous cell cancer of the vulva: radical versus modified radical vulvar surgery. Magrina, JF., Gonzalez-Bosquet, J., Weaver, AL., et al.[2006]

In a pilot study of 31 patients with locally advanced squamous cell carcinoma of the vulva, concurrent chemoradiotherapy followed by radical surgery resulted in a high objective response rate of 91.6% for primary cases and 100% for recurrent cases.

Despite a significant postoperative morbidity rate of 65% and a mortality rate of 13.8%, the treatment showed promise, with 55% of patients with lymph node metastases having no residual disease after surgery, suggesting that chemoradiotherapy could be a viable option for managing this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined preoperative chemoradiotherapy followed by radical surgery in locally advanced vulvar carcinoma. A pilot study. Lupi, G., Raspagliesi, F., Zucali, R., et al.[2013]

Surgery, specifically wide local excision, is the primary treatment for early-stage vulvar cancer, but the presence of close margins (< 8 mm) or multiple positive lymph nodes significantly increases the risk of local recurrence.

Current guidelines for adjuvant radiation therapy in vulvar cancer are primarily based on retrospective studies, highlighting the need for further research to establish optimal radiation doses and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant Radiation in Early Stage Vulvar Cancer: A Review of Indications and Optimal Dose. Khullar, K., Patrich, T., Jabbour, SK., et al.[2022]

In a study of 83 vulvar carcinoma patients treated between 1970 and 1990, the 5-year survival rate was significantly higher (82%) for patients without inguinofemoral lymph node involvement compared to only 40% for those with lymph node metastasis, highlighting the importance of lymph node status in prognosis.

The study reported a high primary morbidity rate of 50%, primarily due to wound healing disturbances and infections, but no primary surgical mortality, indicating that while surgeries were generally safe, they carried a substantial risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of vulvar carcinoma. Haberthür, F., Almendral, AC., Ritter, B.[2020]

The modified oncological approach using V-Y flaps for reconstructive surgery in vulvar cancer patients significantly reduced complication rates, with perineal and inguinal dehiscence rates dropping to 10.5% and 36.84%, respectively, compared to 68.4% and 78.94% in the traditional approach.

Patients undergoing the modified procedure had a much shorter average hospital stay of 14 days, compared to 39.5 days for those who had the traditional surgery, while also showing a lower local recurrence rate of 26.3% at 12 months versus 42.0% at 30 months for the traditional method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

V--Y flap for perineal reconstruction following modified approach to vulvectomy in vulvar cancer. Carramaschi, F., Ramos, ML., Nisida, AC., et al.[2022]

The single-incision radical vulvectomy (SIRV) procedure was performed on 10 patients with vulvar cancer, demonstrating safety and feasibility with minimal blood loss (≤35 mL) and an average hospital stay of 11.7 days.

While some patients experienced minor complications like inguinal lymphoceles and impaired wound healing, no major postoperative issues were reported, suggesting SIRV may be a promising minimally invasive alternative to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of single-incision radical vulvectomy: a novel approach for the treatment of vulvar cancer. He, L., Chen, G., Li, X., et al.[2022]

In a study of 182 patients undergoing surgery for vulvar cancer, short-term complication rates increased significantly with the extent of surgery: 21.8% for vulvar surgery only, 39.6% for sentinel lymph node biopsy (SLNB), and 54.2% for inguinofemoral lymphadenectomy (IFL).

The study found that SLNB had lower complication rates compared to IFL, with severe complications being rare, highlighting the importance of minimizing the extent of surgery to reduce both short- and long-term complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and risk factors in vulvar cancer surgery - A population-based study. Rahm, C., Adok, C., Dahm-Kähler, P., et al.[2022]

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]

In a study of 32 patients with early vulvar cancer, those who underwent simple vulvectomy or wide local excision with ipsilateral superficial inguinal lymphadenectomies (ISIL) experienced significantly lower rates of surgical complications, such as flap dehiscence (8.3% vs. 66.6% in the control group) and lymphedema (0% vs. 13.8%).

The recurrence rates of vulvar cancer were similar between the ISIL group (12.5%) and the control group (9.5%), suggesting that ISIL is a safe alternative to radical surgery without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ipsilateral superficial inguinal lymphadenectomy for the treatment of early cancer of the vulva. Gori, JR., Fritsches, HW., Castaño, R., et al.[2019]

Citations

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/009082589290284P

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A modified radical vulvectomy appears to be efficacious for the vulvar phase of treatment of localized invasive squamous cell carcinoma of the vulva.

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Vulvar cancer - Diagnosis and treatment

Treatment for vulvar cancer usually begins with surgery to remove the cancer. Other treatments may include radiation therapy, chemotherapy, targeted therapy ...

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Radical local excision and radical vulvectomy were performed in 96 and 11 patients, respectively. Thirty-nine patients received adjuvant radiotherapy. The ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24270518/

Vulvar cancer surgery

Primary vulvar cancer may be safely treated with radical/wide local resection. In case of other suspicious lesion or multifocal disease, radical vulvectomy ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0748798322000798

Complications and risk factors in vulvar cancer surgery

Complications of the vulvar wound occurred in 17.6% and no difference between the surgical groups was found. Other short-term complications found were urinary ...

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acsjournals.onlinelibrary.wiley.com

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

Comprehensive management of vulvovaginal cancers - 2025

Whereas no randomized trials have directly compared radical vulvectomy with wide local excision, safety and outcomes appear to be comparable.

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atm.amegroups.org

atm.amegroups.org/article/view/62312/html

Safety and feasibility of single-incision radical vulvectomy

Patients without positive lymph nodes were reported to have a 5-year overall survival rate of approximately 85%, which sharply declined to 39% ...

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mdpi.com

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Conservative Management of Vulvar Cancer—Where ...

In the first half of the 20th century, the 5-year survival rate for vulvar cancer was 15–25% [4]. Patients were generally presented with ...