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

Canadian Cancer Trials Group

Status: Enrolling

Conditions: Vulvar Squamous Cell Carcinoma

Treatments: Other: Active Surveillance; Procedure: Surgery

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06358469

VU2

Details and patient eligibility

About

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?

Full 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).

Enrollment: 249 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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249 participants in 3 patient groups

Sub-Study A: Active Surveillance

Active Comparator group

Description:

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

Treatment:

Other: Active Surveillance

Sub-Study B: Re-excision

Active Comparator group

Description:

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

Treatment:

Procedure: Surgery

Sub-Study B: Active Surveillance

Active Comparator group

Description:

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

Treatment:

Other: Active Surveillance