Assessing treatment needs for early-stage vulvar cancer based on HPV and p53 status
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
This study is testing if early-stage vulvar cancer patients need different treatments based on whether their cancer is linked to HPV or not.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 249 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Canadian Cancer Trials Group Research network |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 11 sites (Kelowna, British Columbia and 10 other locations) |
| Trial ID | NCT06358469 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if early-stage vulvar squamous cell carcinoma (VSCC) patients require different treatment approaches based on laboratory testing of their cancer. Patients will be categorized into two sub-studies depending on whether their cancer is caused by the Human Papilloma Virus (HPV). Those with HPV-related cancer will be monitored without additional surgery, while those without HPV may undergo further surgical intervention or observation. The goal is to tailor treatment to individual patient needs, potentially improving outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed early-stage vulvar squamous cell carcinoma.
Not a fit: Patients with recurrent vulvar squamous cell carcinoma or those with non-squamous cell carcinoma histotypes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for patients with early-stage vulvar cancer, potentially reducing unnecessary surgeries.
How similar studies have performed: Other studies have explored HPV-related treatment stratification in cancers, showing promising results, but this specific approach for vulvar cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC) * Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines * Vulvar resection according to standard of care guidelines * Post-operative margin assessment of tumour clearance, dVIN and p53 status. * Participants' age must be ≥ 18 years old * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French * Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements Exclusion Criteria: * Recurrent vulvar squamous cell carcinoma * Non-squamous cell carcinoma histotypes * Participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy * Primary tumour HPV-I p53 wild-type VSCC * Surgical margins positive for invasive cancer. * Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years * Lymph node positive VSCC or lymph nodes with isolated tumour cells.
Where this trial is running
Kelowna, British Columbia and 10 other locations
- BCCA - Kelowna — Kelowna, British Columbia, Canada (Recruiting)
- BCCA - Vancouver — Vancouver, British Columbia, Canada (Recruiting)
- Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (Recruiting)
- The Jewish General Hospital — Montreal, Quebec, Canada (Not_yet_recruiting)
- Hotel-Dieu de Quebec — Québec, Quebec, Canada (Recruiting)
- CIUSSS de l'Estrie - Centre hospitalier — Sherbrooke, Quebec, Canada (Recruiting)
- Allan Blair Cancer Centre — Regina, Saskatchewan, Canada (Recruiting)
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: Wendy Parulekar
- Email: wparulekar@ctg.queensu.ca
- Phone: 613-533-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.