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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06476639




Registration number
NCT06476639
Ethics application status
Date submitted
17/06/2024
Date registered
26/06/2024

Titles & IDs
Public title
Australian National Vulvar Cancer Trial
Scientific title
A Phase II Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
Secondary ID [1] 0 0
ANVU
Universal Trial Number (UTN)
Trial acronym
ANVU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvar Cancer Stage I 0 0
Vulvar Cancer Stage II 0 0
Lymph Node Metastasis 0 0
Groin Node 0 0
Ultrasound Therapy; Complications 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - High-resolution bilateral groin ultrasound monitoring

Experimental: Participants with normal/negative baseline groin ultrasounds - Intervention Group - Surgical removal of primary tumour and serial high-resolution bilateral groin ultrasound monitoring every 2 months and clinical examination every 3 months (n=120).

No intervention: Participants with normal/negative baseline groin ultrasounds - Standard Group - Surgical removal of primary tumour and upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).

No intervention: Participants with suspicious/indeterminate baseline groin ultrasound - Standard Treatment - Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines.


Diagnosis / Prognosis: High-resolution bilateral groin ultrasound monitoring
Participants in the Interventional Group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months and a clinical examination every 3 months, for a follow up period of 12 months. Senior imaging specialists review bilateral ultrasound scans for positive lymph nodes or suspicious findings, promptly sending reports to the primary care physician and trial manager if detected within 3 business days. Subsequently, participants consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with bi-monthly ultrasounds based on preference and clinician guidance.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of enlarged clinically palpable groin nodes (groin metastases) in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND.
Timepoint [1] 0 0
12 months after surgery
Secondary outcome [1] 0 0
Patient Reported Outcomes (PROMs)
Timepoint [1] 0 0
12 months after surgery
Secondary outcome [2] 0 0
Health Related Quality of Life (HRQL)
Timepoint [2] 0 0
12 months after surgery
Secondary outcome [3] 0 0
Pain
Timepoint [3] 0 0
12 months after surgery
Secondary outcome [4] 0 0
Adverse events
Timepoint [4] 0 0
12 months after surgery
Secondary outcome [5] 0 0
Lower limb lymphoedema
Timepoint [5] 0 0
12 months after surgery
Secondary outcome [6] 0 0
Cost-effectiveness
Timepoint [6] 0 0
12 months after surgery
Secondary outcome [7] 0 0
Disease-free survival
Timepoint [7] 0 0
12 months after surgery
Secondary outcome [8] 0 0
Overall survival
Timepoint [8] 0 0
12 months after surgery
Secondary outcome [9] 0 0
Clinical accuracy of high-resolution serial ultrasound to predict groin lymph node involvement
Timepoint [9] 0 0
12 months after surgery
Secondary outcome [10] 0 0
Utility of circulating tumour DNA to reliably reflect the presence or absence of positive groin lymph nodes
Timepoint [10] 0 0
Study duration of up to 15 years
Secondary outcome [11] 0 0
Utility of plasma to reliably reflect the presence or absence of positive groin lymph nodes
Timepoint [11] 0 0
Study duration of up to 15 years
Secondary outcome [12] 0 0
Utility of serum to reliably reflect the presence or absence of positive groin lymph nodes
Timepoint [12] 0 0
Study duration of up to 15 years
Secondary outcome [13] 0 0
Utility of tumour mutations to reliably reflect the presence or absence of positive groin lymph nodes
Timepoint [13] 0 0
Study duration of up to 15 years

Eligibility
Key inclusion criteria
* Females, over 18 years, with histologically confirmed SCC, adenocarcinoma, or melanoma of the vulvar
* Clinically stage 1 or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
* Undergo IFL/SNB according to local clinical practice management guidelines
* Willing and able to comply with all study requirements, timing and/or nature of required assessments.
* Signed written informed consent
* Negative (serum or urine) pregnancy (BHCG) test = 30 days of surgery ONLY in pre-menopausal women and women < 2 years after the onset of menopause.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
* SCC of the vulvar with depth of invasion =1 mm
* Clinical or medical imaging evidence of regional and/or distant metastatic disease
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
* Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ
* Estimated life expectancy of =6 months

Study design
Purpose of the study
Other
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
Parallel
Other design features
Phase
Phase 2
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
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2029
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
The Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
The Royal Darwin Hospital - Darwin
Recruitment hospital [4] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [5] 0 0
Mater Hospital - Brisbane
Recruitment hospital [6] 0 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [8] 0 0
Buderim Private Hospital - Buderim
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [12] 0 0
Royal Women's Hospital - Parkville
Recruitment hospital [13] 0 0
St John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
0810 - Darwin
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4000 - Brisbane
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4556 - Buderim
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3052 - Parkville
Recruitment postcode(s) [12] 0 0
6904 - Subiaco

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair, MD
Address 0 0
Director, Queensland Centre for Gynaecological Cancer Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brianna Armstrong
Address 0 0
Country 0 0
Phone 0 0
07 3346 5063
Fax 0 0
Email 0 0
bri.armstrong@uq.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06476639