Clinical trial NCT06358469: STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
Official title: STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvar Squamous Cell Carcinoma
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: Australia New Zealand Gynaecological Oncology Group
First posted: 2024-04-10
Enrollment: 249
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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).

Eligibility 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
* 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

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: HPV-I and HPV-A VSCC cohorts: Recurrence-free survival
timeFrame: 3 years
measure: HPV-I and HPV-A VSCC cohorts: Disease-specific survival
timeFrame: 3 years
measure: HPV-I and HPV-A VSCC cohorts: Overall-survival
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30
timeFrame: 3 years
measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34
timeFrame: 3 years
measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale
timeFrame: 3 years
measure: HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn
timeFrame: 3 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BCCA - Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Quebec City
country: Canada
facility: Hotel-Dieu de Quebec
state: Quebec
Study officials:
affiliation: University of British Columbia, Vancouver, BC, Canada
name: Amy Jamieson
role: STUDY_CHAIR
affiliation: BCCA-Vancouver Cancer Centre, Vancouver, BC Canada
name: Jessica McAlpine
role: STUDY_CHAIR
References: