Vulvar Squamous Cell Carcinoma
Conditions
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).
Interventions
PROCEDURESurgery
Re-excision of vulvar cancer margin
OTHERActive Surveillance
The investigator will follow the patient to watch for side effects and keep track of patient's health
Sponsors
Canadian Cancer Trials Group
Australia New Zealand Gynaecological Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| HPV-I and HPV-A VSCC cohorts: Recurrence-free survival | 3 years |
| HPV-I and HPV-A VSCC cohorts: Disease-specific survival | 3 years |
| HPV-I and HPV-A VSCC cohorts: Overall-survival | 3 years |
| 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 |
| HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 | 3 years |
| HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 | 3 years |
| HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale | 3 years |
| HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn | 3 years |
Countries
Canada, New Zealand
Contacts
CONTACTWendy Parulekar
STUDY_CHAIRAmy Jamieson
University of British Columbia, Vancouver, BC, Canada
STUDY_CHAIRJessica McAlpine
BCCA-Vancouver Cancer Centre, Vancouver, BC Canada
Outcome results
None listed