Vulvar Cancer Stage IPhase 3ANVUNCT06476639
A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
A Phase 3 study testing High-resolution bilateral groin ultrasound monitoring in people with Vulvar Cancer Stage I and Vulvar Cancer Stage II, run by Queensland Centre for Gynaecological Cancer at 9 sites in Australia.
Trial summary
This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer Stage I, Vulvar Cancer Stage II, Lymph Node Metastasis
- What is being tested?
- High-resolution bilateral groin ultrasound monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 9 sitesAustralia
- Study dates
- 1 Jun 2026to 31 Dec 2035
- Phase
- Phase 3
- 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
- Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva
- Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
- Willing and able to 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.
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
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Australia9 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Martin Oehler, +61 8 8222 4816, martin.oehler@adelaide.edu.au
Martin Oehler
The Wesley Hospital
Auchenflower, Queensland, 4066
Brianna Armstrong, +61 7 3346 5063, bri.armstrong@uq.edu.au
Sara Baniahmadi, +61 7 3346 5073, sara.baniahmadi@health.qld.gov.au
St Andrew's War Memorial Hospital
Brisbane, Queensland, 4000
Brianna Armstrong, 07 3346 5063, bri.armstrong@uq.edu.au
Sara Baniahmadi, 0733465073, s.baniahmadi@uq.edu.au
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Brianna Armstrong, 07 3346 5063, bri.armstrong@uq.edu.au
Sara Baniahmadi, 07 3346 5073, s.baniahmadi@uq.edu.au
Buderim Private Hospital
Buderim, Queensland, 4556
Brianna Armstrong, 0733465063, bri.armstrong@uq.edu.au
Sara Baniahmadi, 0733465073, s.baniahmadi@uq.edu.au
The Royal Darwin Hospital
Darwin, Northern Territory, 0810
Michelle Harris, MD, Michelle.Harris2@nt.gov.au
Michelle Harris, MD
Mercy Hospital for Women
Heidelberg, Victoria, 3084
Adam Pendlebury, MD, cgo@dradampendlebury.com.au
Adam Pendlebury
John Hunter Hospital
Newcastle, New South Wales, 2305
Anne Mellon, anne.mellon@health.nsw.gov.au
Rachael O'Sullivan, MD
Royal Women's Hospital
Parkville, Victoria, 3052
Estefania Vicario, estefania.vicario@thewomens.org.au
Niveditha Rajadevan, MD, niveditha.rajadevan@thewomens.org.au
About this study
This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.
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 sentinel node biopsy (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. The ANVU trial will determine the value of serial groin ultrasound examinations in stage 1b and 2 vulvar cancer patients and whether it is feasible and safe to de-escalate the extent of vulvar cancer surgery to achieve improved outcomes for affected patients.
Women with this rare cancer bear an unacceptably high (and potentially avoidable) treatment-related burden. This clinical trial is the first step to address this problem in a novel yet pragmatic way. The potential overall outcome of ANVU could be a novel, less invasive alternative to vulvar cancer LND hypothesised to be associated with significantly less morbidity, without compromising survival.
- Conditions
- Vulvar Cancer Stage I, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node, Ultrasound Therapy; Complications
- Being tested
- High-resolution bilateral groin ultrasound monitoring
- 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 monitoringDiagnostic test
Participants in the Interventional Group will undergo surgical excision of the primary tumour, either via radical local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months for 12 months, and at month 15 and month 18, and a clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 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 within 5 business days. If positive nodes are detected, participants will consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with serial ultrasounds and clinical exams based on preference and clinician guidance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with normal/negative baseline groin ultrasounds - Intervention Group | Experimental | Surgical removal of primary tumour and serial high-resolution bilateral groin ultrasound monitoring every 2 months for 12 months, and at month 15 and month 18, with clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 months (n=360). Receives: Diagnostic Test: High-resolution bilateral groin ultrasound monitoring |
| Participants with normal/negative baseline groin ultrasounds - Standard Group | No intervention | Surgical removal of primary tumour and upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=120). |
| Participants with suspicious/indeterminate baseline groin ultrasound - Standard Treatment | 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=160). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival following the development of groin node metastasis (GNS, Groin Node-related Survival) at 30 months.
Determine survival following the development of groin node metastasis (GNS, Groin Node-related Survival) in patients with vulvar cancer randomised to serial high-resolution groin USM compared to standard upfront surgical groin LND at 30 months.
Measured: 30 months
Secondary outcomes (10)
Compare return to usual daily activities at 18 months between the groups
Return to usual daily activities at 18 months measured using the PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Measured: 18 months
HRQL and PROMS as measured by the EQ-5D and FACT-V at baseline, 8 weeks, 6 months, 12 months, 18 months, 24 months, and 30 months.
Compare Patient Reported Outcomes (PROMs) and Health Related Quality of Life (HRQL) between the groups.
Measured: 30 months
Morbidity at 12 months after surgery.
Compare pain and adverse events (AEs) (morbidity) between the groups.
Measured: 12 months
Incidence of lower limb lymphoedema up to 30 months after surgery.
Compare the incidence of lower limb lymphoedema at 30 months post-surgery between the groups.
Measured: 30 months
Cost and cost-effectiveness at 12 months post-surgery.
Compare cost and cost-effectiveness between the groups.
Measured: 12 months
Fear of recurrence at baseline, 8 weeks, 6 months, 12 months, 18 months, 24 months, and 30 months.
Compare fear of recurrence between the groups.
Measured: 30 months
Clinical accuracy of high-resolution ultrasound to predict groin lymph node involvement.
Determine the diagnostic accuracy of standardised, high-resolution groin ultrasound to identify groin node metastasis.
Measured: 18 months
Disease-free survival (DFS) and overall survival (OS) at 30 months.
Compare disease free and overall survival between the groups.
Measured: 30 months
Determine compliance with serial ultrasound scans.
Compliance with serial ultrasound scans.
Measured: 18 months
Utility of biomarkers to reliably reflect the presence or absence of positive groin lymph nodes, and explore novel biomarkers for vulvar cancer.
Assess the role of blood and tissue molecular biomarkers to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance.
Measured: 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 posted26 Jun 2024
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (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 IStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase III, open label, multicentre, three-group, randomised clinical trial. 640 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 (3:1 randomisation). The Intervention Group will receive serial bilateral groin node ultrasounds and clinical examinations for 18 months (groin lymph nodes are not removed). The Standard Group will undergo upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines). Participants with abnormal 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
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- Royal Brisbane and Women's Hospital, The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Andreas Obermair, MD, Study chair, Director, Queensland Centre for Gynaecological Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476639
- Sponsor's protocol ID
- ANVU
- Acronym
- ANVU
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2024
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
- ClinicalTrials.gov ID
- NCT06476639
- Acronym / sponsor ID
- ANVU / ANVU
- Conditions
- Vulvar Cancer Stage I, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node, Ultrasound Therapy; Complications
- Keywords
- Vulvar Cancer, Ultrasound Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- Royal Brisbane and Women's Hospital, The University of Queensland
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 26 Jun 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 a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.
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 sentinel node biopsy (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. The ANVU trial will determine the value of serial groin ultrasound examinations in stage 1b and 2 vulvar cancer patients and whether it is feasible and safe to de-escalate the extent of vulvar cancer surgery to achieve improved outcomes for affected patients.
Women with this rare cancer bear an unacceptably high (and potentially avoidable) treatment-related burden. This clinical trial is the first step to address this problem in a novel yet pragmatic way. The potential overall outcome of ANVU could be a novel, less invasive alternative to vulvar cancer LND hypothesised to be associated with significantly less morbidity, without compromising survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A phase III, open label, multicentre, three-group, randomised clinical trial. 640 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 (3:1 randomisation). The Intervention Group will receive serial bilateral groin node ultrasounds and clinical examinations for 18 months (groin lymph nodes are not removed). The Standard Group will undergo upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines). Participants with abnormal 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 - Intervention Group | Experimental | Diagnostic Test: High-resolution bilateral groin ultrasound monitoringSurgical removal of primary tumour and serial high-resolution bilateral groin ultrasound monitoring every 2 months for 12 months, and at month 15 and month 18, with clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 months (n=360). |
| Participants with normal/negative baseline groin ultrasounds - Standard Group | No intervention | –Surgical removal of primary tumour and upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=120). |
| Participants with suspicious/indeterminate baseline groin ultrasound - Standard Treatment | 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=160). |
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)
- Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva
- Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
- Willing and able to 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
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 monitoringParticipants in the Interventional Group will undergo surgical excision of the primary tumour, either via radical local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months for 12 months, and at month 15 and month 18, and a clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 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 within 5 business days. If positive nodes are detected, participants will consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with serial ultrasounds and clinical exams based on preference and clinician guidance. | Diagnostic test | Participants with normal/negative baseline groin ultrasounds - Intervention Group |
Primary outcome
Survival following the development of groin node metastasis (GNS, Groin Node-related Survival) at 30 months.
Time frame: 30 months
Determine survival following the development of groin node metastasis (GNS, Groin Node-related Survival) in patients with vulvar cancer randomised to serial high-resolution groin USM compared to standard upfront surgical groin LND at 30 months.
10 secondary outcomes
Compare return to usual daily activities at 18 months between the groups
Time frame: 18 months
HRQL and PROMS as measured by the EQ-5D and FACT-V at baseline, 8 weeks, 6 months, 12 months, 18 months, 24 months, and 30 months.
Time frame: 30 months
Morbidity at 12 months after surgery.
Time frame: 12 months
Incidence of lower limb lymphoedema up to 30 months after surgery.
Time frame: 30 months
Cost and cost-effectiveness at 12 months post-surgery.
Time frame: 12 months
Fear of recurrence at baseline, 8 weeks, 6 months, 12 months, 18 months, 24 months, and 30 months.
Time frame: 30 months
Clinical accuracy of high-resolution ultrasound to predict groin lymph node involvement.
Time frame: 18 months
Disease-free survival (DFS) and overall survival (OS) at 30 months.
Time frame: 30 months
Determine compliance with serial ultrasound scans.
Time frame: 18 months
Utility of biomarkers to reliably reflect the presence or absence of positive groin lymph nodes, and explore novel biomarkers for vulvar cancer.
Time frame: 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 24 Mar 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.
Andreas Obermair, MD study chair
Director, Queensland Centre for Gynaecological Cancer Research
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High-resolution bilateral groin ultrasound monitoring in people with Vulvar Cancer Stage I and Vulvar Cancer Stage II, run by Queensland Centre for Gynaecological Cancer at 9 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: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Brianna Armstrong (+61 7 3346 5063, anvutrial@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival following the development of groin node metastasis (GNS, Groin Node-related Survival) at 30 months. (time frame: 30 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 24 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.