Vulvar Cancer Stage IbNODENCT06264167
NODE (groiN ultrasOunD cancEr)
A study testing High-resolution bilateral groin ultrasound surveillance in people with Vulvar Cancer Stage Ib and Vulvar Cancer Stage II, run by Queensland Centre for Gynaecological Cancer at 5 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer Stage Ib, Vulvar Cancer Stage II, Lymph Node Metastasis
- What is being tested?
- High-resolution bilateral groin ultrasound surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesAustralia
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, over 18 years, with histologically confirmed SCC or adenocarcinoma 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)
Who cannot join
- Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Crystal Eldridge, (08) 7074 4404, crystal.eldridge@sa.gov.au
Kathy Heyman, (08) 7074 4404, kathy.heyman@sa.gov.au
- Recruiting
St Andrew's War Memorial Hospital
Brisbane, Queensland, 4000
Sara Baniahmadi, 07 3346 5073, s.baniahmadi@uq.edu.au
Brianna Armstrong, 07 3346 5063, bri.armstrong@uq.edu.au
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Sara Baniahmadi, 07 3346 5073, s.baniahmadi@uq.edu.au
Brianna armstrong, 07 3346 5063, bri.armstrong@uq.edu.au
- Not yet recruiting
The Wesley Hospital
Brisbane, Queensland, 4066
Sara Baniahmadi, 07 3346 5073, s.baniahmadi@uq.edu.au
Brianna Armstrong, 07 3346 5063, bri.armstrong@uq.edu.au
- Recruiting
Buderim Private Hospital
Sunshine Coast, Queensland, 4556
Sara Baniahmadi, 07 3346 5073, s.baniahmadi@uq.edu.au
Brianna Armstrong, 07 3346 5063, bri.armstrong@uq.edu.au
About this study
Official title: Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer
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 for 12 months.
Read the 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.
- Conditions
- Vulvar Cancer Stage Ib, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node, Ultrasound Therapy; Complications
- Being tested
- High-resolution bilateral groin ultrasound surveillance
- Keywords
- Vulvar Cancer, Ultrasound Therapy
- Medical subject headings
- Vulvar Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution bilateral groin ultrasound surveillanceDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with normal/negative baseline groin ultrasounds | Experimental | Interventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13). Receives: Diagnostic Test: High-resolution bilateral groin ultrasound surveillance |
| Participants with normal/negative baseline groin ultrasounds - Standard Care | No intervention | Standard Treatment: receive upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=7). |
| Participants with suspicious/indeterminate baseline groin ultrasound | No intervention | 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 (n=10). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The feasibility of randomisation into (1) LND (IFL vs SNB) or (2) high-resolution bilateral groin ultrasound surveillance every 2 months will be determined through a practical sample size of n=20. Feasibility is declared if 30% of eligible patients (n=6 or more) can be randomised.
Measured: 12 months
Secondary outcomes (4)
Utility of tumour mutations to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of tumour mutations between positive and negative lymph nodes.
Measured: Study duration up to 15 years
Utility of circulating tumour DNA to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of circulating tumour DNA between positive and negative lymph nodes.
Measured: Study duration up to 15 years
Utility of plasma to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of plasma between positive and negative lymph nodes.
Measured: Study duration up to 15 years
Utility of serum to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of serum between positive and negative lymph nodes.
Measured: Study duration up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Cancer Stage IbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- Royal Brisbane and Women's Hospital, St Andrew's War Memorial Hospital, Buderim Private Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264167
- Sponsor's protocol ID
- NODE
- Acronym
- NODE
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer
- ClinicalTrials.gov ID
- NCT06264167
- Acronym / sponsor ID
- NODE / NODE
- Conditions
- Vulvar Cancer Stage Ib, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node, Ultrasound Therapy; Complications
- Keywords
- Vulvar Cancer, Ultrasound Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- Royal Brisbane and Women's Hospital, St Andrew's War Memorial Hospital, Buderim Private Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 for 12 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants with normal/negative baseline groin ultrasounds | Experimental | Diagnostic Test: High-resolution bilateral groin ultrasound surveillanceInterventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13). |
| Participants with normal/negative baseline groin ultrasounds - Standard Care | No intervention | –Standard Treatment: receive upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=7). |
| Participants with suspicious/indeterminate baseline groin ultrasound | No intervention | –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 (n=10). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women, over 18 years, with histologically confirmed SCC or adenocarcinoma 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
Key exclusion criteria (5 listed)
- Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-resolution bilateral groin ultrasound surveillanceParticipants 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. | Diagnostic test | Participants with normal/negative baseline groin ultrasounds |
Primary outcome
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.
Time frame: 12 months
The feasibility of randomisation into (1) LND (IFL vs SNB) or (2) high-resolution bilateral groin ultrasound surveillance every 2 months will be determined through a practical sample size of n=20. Feasibility is declared if 30% of eligible patients (n=6 or more) can be randomised.
4 secondary outcomes
Utility of tumour mutations to determine positive lymph node metastasis.
Time frame: Study duration up to 15 years
Utility of circulating tumour DNA to determine positive lymph node metastasis.
Time frame: Study duration up to 15 years
Utility of plasma to determine positive lymph node metastasis.
Time frame: Study duration up to 15 years
Utility of serum to determine positive lymph node metastasis.
Time frame: Study duration up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-resolution bilateral groin ultrasound surveillance in people with Vulvar Cancer Stage Ib and Vulvar Cancer Stage II, run by Queensland Centre for Gynaecological Cancer at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Baniahmadi (07 3346 5073, s.baniahmadi@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.