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NCT06358469 | Not yet recruiting | Vulvar Squamous Cell Carcinoma

STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
Sponsor:

Canadian Cancer Trials Group

Brief Summary:

This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?

Condition or disease

Vulvar Squamous Cell Carcinoma

Intervention/treatment

Surgery

Active Surveillance

Phase

Not Applicable

Detailed Description:

This study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. The usual approach is defined as care most people get for early-stage vulvar cancer. The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended. For patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).

Study Type : Interventional
Estimated Enrollment : 249 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
Actual Study Start Date : June 30, 2024
Estimated Primary Completion Date : June 30, 2030
Estimated Study Completion Date : November 30, 2031
Arm Intervention/treatment

Active Comparator: Sub-Study A: Active Surveillance

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

Other: Active Surveillance

Active Comparator: Sub-Study B: Re-excision

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

Procedure: Surgery

Active Comparator: Sub-Study B: Active Surveillance

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

Other: Active Surveillance
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Histologically confirmed primary 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
  • 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
STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

Location Details

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STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

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