Trial Title:
NODE (groiN ultrasOunD cancEr)
NCT ID:
NCT06264167
Condition:
Vulvar Cancer Stage Ib
Vulvar Cancer Stage II
Lymph Node Metastasis
Groin Node
Ultrasound Therapy; Complications
Conditions: Official terms:
Lymphatic Metastasis
Vulvar Neoplasms
Conditions: Keywords:
Vulvar Cancer
Ultrasound Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Feasibility trial, open label, three-group, randomised clinical trial
30 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will
receive a bilateral groin node ultrasound up to 30 days prior to planned surgery:
Participants with normal/negative baseline groin ultrasounds will be randomly assigned to
two groups (2:1 randomisation): one group undergoing radical procedures (groin lymph
nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with
clinical examinations every 2 months, and the other group undergoing upfront full groin
LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical
practice management guidelines).
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.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
High-resolution bilateral groin ultrasound surveillance
Description:
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.
Arm group label:
Participants with normal/negative baseline groin ultrasounds
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.
Detailed description:
Treatment of vulvar cancer causes significant morbidity. Despite being a rare cancer, at
least 2500 survivors of vulvar cancer live in Australia. Most survivors live with the
detrimental, life-long impacts resulting from their cancer treatment because there are
currently no alternatives to mitigate these impacts. The personal and societal burden
this entails is significant. To control such cancer-associated burden is a national
priority.
Clinical palpation of the groin region and computed tomography (CT) scans do not reliably
detect groin node involvement. Hence, current clinical guidelines recommend all women
diagnosed at apparent Stage I or II have a surgical groin LND. This can be performed as a
full IFL (full LND) to remove all groin nodes, or as a SNB to remove selected (one or
two) nodes. SNB is less invasive, however, is appropriate only for vulvar cancers <4cm in
diameter and unifocal tumours (~50% of all Stage I and II vulvar cancers). SNB is also
associated with a false negative rate (10%) that increases the risk of undetected nodes.
In 25% of cases (~80 Australian women per year), groin LND will reveal positive nodes
(i.e., metastases), which triggers a referral for radiation treatment. If positive groin
nodes are missed, and over time become enlarged, clinically palpable and attached to the
overlying skin, >90% of women will die within 12 months, despite subsequent treatment.
Conversely, if groin node involvement is detected early (e.g., by ultrasound) while still
small, survival outcomes are excellent. Ultrasound technology is potentially as accurate
as LND due to recent advances in resolution and technologies such as 2D/3D volumetric
assessments and tissue flow. Furthermore, ultrasound is superior to medical resonance
imaging (MRI), and to standard CT and positron emission tomography (PET) scans in
capturing groin node involvement because it has a higher resolution, avoids harmful
radiation and the technology is readily accessible outside of high-volume metropolitan
areas.
The investigators propose to reduce surgical morbidity by replacing upfront groin LND for
vulvar cancer patients with serial high-resolution ultrasound to detect groin metastases.
Groin LND will only be necessary for the few women with ultrasound-detected metastases
when they are still small. This feasibility study (NODE - groiN ultrasOunD cancer) will
determine the value of randomized serial groin ultrasound examinations in stage I and II
vulvar cancer patients and whether it is feasible and safe for the investigators to
de-escalate the extent of vulvar cancer surgery, aiming to achieve improved outcomes for
affected patients.
Australian women with this rare cancer bear an unacceptably high (and potentially
avoidable) treatment-related burden. This feasibility study is the first step to address
this problem in a novel yet pragmatic way. The overall outcome of NODE is a novel, less
invasive alternative to vulvar cancer LND associated with significantly less morbidity,
without compromising survival.
Criteria for eligibility:
Criteria:
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)
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Andrew's War Memorial Hospital
Address:
City:
Brisbane
Zip:
4000
Country:
Australia
Contact:
Last name:
Sara Baniahmadi
Phone:
07 3346 5073
Email:
s.baniahmadi@uq.edu.au
Investigator:
Last name:
Andreas Obermair, Prof
Email:
Principal Investigator
Facility:
Name:
Royal Brisbane and Women's Hospital
Address:
City:
Brisbane
Zip:
4029
Country:
Australia
Contact:
Last name:
Sara Baniahmadi
Phone:
07 3346 5073
Email:
s.baniahmadi@uq.edu.au
Contact backup:
Last name:
Avalon Knott
Phone:
07 3346 5073
Email:
a.knott@uq.edu.au
Investigator:
Last name:
Andrea Garrett, Dr
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Queensland Centre for Gynaecological Cancer
Agency class:
Other
Collaborator:
Agency:
Royal Brisbane and Women's Hospital
Agency class:
Other
Source:
Queensland Centre for Gynaecological Cancer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06264167
