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

Vulvar Squamous Cell Carcinoma Clinical Trial

— STRIVE  

Official title:

STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358469
• Other study ID #: VU2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: November 30, 2031

Study information

• Verified date: April 2024
• Source: Canadian Cancer Trials Group
• Contact: Wendy Parulekar
• Phone: 613-533-6430
• Email: wparulekar[@]ctg.queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 249
• Est. completion date: November 30, 2031
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Vulvar Squamous Cell Carcinoma

Intervention

Procedure:
• Surgery
Re-excision of vulvar cancer margin

Other:
• Active Surveillance
The investigator will follow the patient to watch for side effects and keep track of patient's health

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Australia New Zealand Gynaecological Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Recurrence-free survival		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Disease-specific survival		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Overall-survival		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34		3 years
Secondary	HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale		3 years
Secondary	HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn		3 years