No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
249 (estimated)
Sponsor
British Columbia Cancer Agency · Other
Who this trial is looking for
This trial is looking for women with vulvar squamous cell carcinoma to see if treating them based on their HPV and p53 status can improve results. Participants will undergo surgery tailored to their specific cancer characteristics.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with vulvar squamous cell carcinoma.
I am at FIGO stages I or II of the disease.
I am 18 years old or older.
I can provide my consent to participate.
You may not be able to join if
I have recurrent vulvar squamous cell carcinoma.
I have a different type of cancer than squamous cell carcinoma.
I am at FIGO stages III or IV of the disease.
I have been referred for radiation therapy due to close margins.
My surgical margins are positive for cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with hum…
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon, arising mostly in older women and has been neglected in research and clinical trials. Over the recent years, investigators have learned that the most common type of vulvar cancer; vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave differently with different risks of recurrence, and different response to treatments. HPV-I VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of patients with aggressive disease. Currently treatment is the same for all women with vulvar cancer, and consequently many women may be overtreated, and many women are not treated enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no longer be appropriate. The investigators aim in this study is to see if personalizing surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve outcomes.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
* Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
* Margin status after primary surgery:
* HPV-I VSCC: margins are negative for cancer but \<8mm, and/or…
Inclusion Criteria:
* Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma
* Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II disease
* Margin status after primary surgery:
* HPV-I VSCC: margins are negative for cancer but \<8mm, and/or positive for dVIN, and/or positive for p53 abnormality on IHC
* HPV-A VSCC: margins are negative for cancer but \<8mm (regardless of in-situ (HSIL) margin status)
* Age ≥18 years old
* 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.
Exclusion Criteria:
* Recurrent vulvar squamous cell carcinoma
* Non-squamous cell carcinoma histotypes
* FIGO stage III- IV disease
* Patients referred for adjuvant radiation for close margins
* Margins positive for cancer
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