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Trial Title:
STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
NCT ID:
NCT06358469
Condition:
Vulvar Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Re-excision of vulvar cancer margin
Arm group label:
Sub-Study B: Re-excision
Intervention type:
Other
Intervention name:
Active Surveillance
Description:
The investigator will follow the patient to watch for side effects and keep track of
patient's health
Arm group label:
Sub-Study A: Active Surveillance
Arm group label:
Sub-Study B: Active Surveillance
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).
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 30, 2024
Completion date:
November 30, 2031
Lead sponsor:
Agency:
Canadian Cancer Trials Group
Agency class:
Other
Collaborator:
Agency:
Australia New Zealand Gynaecological Oncology Group
Agency class:
Other
Source:
Canadian Cancer Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06358469
