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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/NCT06264167




Registration number
NCT06264167
Ethics application status
Date submitted
9/01/2024
Date registered
16/02/2024
Date last updated
16/02/2024

Titles & IDs
Public title
NODE (groiN ultrasOunD cancEr)
Scientific title
Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Queensland Women With Vulvar Cancer
Secondary ID [1] 0 0
NODE
Universal Trial Number (UTN)
Trial acronym
NODE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvar Cancer Stage Ib 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 surveillance

Experimental: Participants with normal/negative baseline groin ultrasounds - Interventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13).

No Intervention: Participants with normal/negative baseline groin ultrasounds - Standard Care - Standard Treatment: receive 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 - 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 surveillance
Participants in the Interventional Treatment (serial ultrasounds) group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, follow-up appointments occur bi-monthly for 12 months, involving a clinical examination and groin ultrasound. 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
Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Utility of tumour mutations to determine positive lymph node metastasis.
Timepoint [1] 0 0
Study duration up to 15 years
Secondary outcome [2] 0 0
Utility of circulating tumour DNA to determine positive lymph node metastasis.
Timepoint [2] 0 0
Study duration up to 15 years
Secondary outcome [3] 0 0
Utility of plasma to determine positive lymph node metastasis.
Timepoint [3] 0 0
Study duration up to 15 years
Secondary outcome [4] 0 0
Utility of serum to determine positive lymph node metastasis.
Timepoint [4] 0 0
Study duration up to 15 years

Eligibility
Key inclusion criteria
- Women, over 18 years, with histologically confirmed SCC, adenocarcinoma or melanoma of
the vulva

- Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest),
without evidence of regional or distant metastatic disease

- Participant must be suitable to undergo IFL/SNB according to local clinical practice
management guidelines

- Signed written informed consent

- Negative serum pregnancy test = 30 days of surgery in pre-menopausal women and women <
2 years after the onset of menopause

- Patient lives within 40 km of a medical diagnostic imaging centre (site investigator
approval required for special circumstances)
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)

- Squamous cell carcinoma (SCC) of the vulva 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
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
1/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
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
This study is an open label, prospective, experimental, randomised clinical trial. The
primary aim of this study is to determine whether it is feasible to randomise vulvar cancer
patients into one of two treatment arms:1) surgical groin node dissection (as delivered
though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2)
serial high-resolution bilateral groin ultrasound surveillance and clinical examination every
2 months.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06264167
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sara Baniahmadi
Address 0 0
Country 0 0
Phone 0 0
07 3346 5073
Fax 0 0
Email 0 0
s.baniahmadi@uq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06264167