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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05576831




Registration number
NCT05576831
Ethics application status
Date submitted
1/10/2022
Date registered
13/10/2022
Date last updated
14/08/2023

Titles & IDs
Public title
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision
Scientific title
STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision: STRIVE Study
Secondary ID [1] 0 0
STRIVE
Universal Trial Number (UTN)
Trial acronym
STRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvar Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Re-excision

No Intervention: HPV-A VSCC - Patients with HPV-A VSCC and margins that are negative for cancer but <8mm (regardless of in-situ (HSIL) margin status) will be eligible for the de-escalation prospective study.

Experimental: HPV-I VSCC - If the margins are negative for cancer but <8mm, or positive for Differentiated vulvar intraepithelial neoplasia (dVIN), and/or positive for p53 abnormality on IHC, these patients will be randomized (2:1) to further re-excision vs observation only.


Treatment: Surgery: Re-excision
Re-excise (one take back only) Excise scar aiming for 1-2cm margin
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local Vulvar Disease Recurrence - Local vulvar disease recurrence rate (within 3 years) in HPV-I and HPV-A vulvar squamous cell carcinoma
Timepoint [1] 0 0
3 years from study enrollment
Secondary outcome [1] 0 0
Health Economic Impact of implementation of HPV and p53 stratified treatment algorithms - Measure the delta in surgical parameters (surgical take backs, longer hospital stay for more extensive surgery)
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
Patient Reported Outcome EORTC QLQ-C30 - Measures subject's physical, psychological and social functions.
Timepoint [2] 0 0
Preoperatively, after surgery at 4-6 weeks, 4 months, 8 months and 12 months, through study completion, an average of 1 year
Secondary outcome [3] 0 0
Patient Reported Outcome EORTC QLQ-VU34 vulva-specific module - Measures symptoms or problems related to the genital area
Timepoint [3] 0 0
through study completion, an average of 1 year
Secondary outcome [4] 0 0
Patient Decisional Conflict Scale - Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after treatment
Timepoint [4] 0 0
Preoperative
Secondary outcome [5] 0 0
Disease-specific survival is defined as the time from study enrolment to the time of death from vulvar cancer. Overall survival is defined as the time from study enrolment to the time of death from any cause.
Timepoint [5] 0 0
Every 4 months for first 3 years
Secondary outcome [6] 0 0
Proportion of patients who had p16 IHC and in HPV-I VSCC who had p53 IHC performed on resection margin in an acceptable turnaround time ie >85% of patients tumours had this performed and reported within 21 days of surgery
Timepoint [6] 0 0
through study completion, up to 3 years

Eligibility
Key inclusion criteria
- Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma

- Surgically staged FIGO (International Federation of Gynaecology and Obstetrics) I-II
disease

- Margin status after primary surgery:

- HPV-I VSCC: margins are negative for cancer but <8mm, and/or positive for dVIN,
and/or positive for p53 abnormality on IHC

- HPV-A VSCC: margins are negative for cancer but <8mm (regardless of in-situ
(HSIL) margin status)

- Age =18 years old

- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrollment in
the trial to document their willingness to participate. A similar process must be
followed for sites outside of Canada as per their respective cooperative group's
procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recurrent vulvar squamous cell carcinoma

- Non-squamous cell carcinoma histotypes

- FIGO stage III- IV disease

- Patients referred for adjuvant radiation for close margins

- Margins positive for cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
249
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia

Funding & Sponsors
Primary sponsor type
Other
Name
British Columbia Cancer Agency
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gynecologic Cancer Initiative
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australia New Zealand Gynaecological Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Canadian Cancer Trials Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Vulvar cancer affects the external genitalia of women. This type of cancer is uncommon,
arising mostly in older women and has been neglected in research and clinical trials. Over
the recent years, investigators have learned that the most common type of vulvar cancer;
vulvar squamous cell carcinoma (VSCC) develops from pre-cancerous lesions via different
pathways. One pathway is associated with human papillomavirus (HPV) infection, and another is
related to chronic inflammatory skin conditions (and not HPV). The VSCCs arising from these
two principal pathways; HPV- associated (HPV A) and HPV-independent (HPV I), behave
differently with different risks of recurrence, and different response to treatments. HPV-I
VSCC are further defined by mutations in TP53 (Tumor Protein 53), which identify a group of
patients with aggressive disease. Currently treatment is the same for all women with vulvar
cancer, and consequently many women may be overtreated, and many women are not treated
enough. Given evolving knowledge of this disease, this 'one size fits all' approach may no
longer be appropriate. The investigators aim in this study is to see if personalizing
surgical therapy for patients with vulvar cancer based on HPV and TP53 status will improve
outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05576831
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Amy Jamieson, MD
Address 0 0
BC Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Jamieson, MD
Address 0 0
Country 0 0
Phone 0 0
604-875-4268
Fax 0 0
Email 0 0
Amy.Jamieson@vch.ca
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05576831