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
NCT ID: NCT06476639
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
640 participants
INTERVENTIONAL
2026-01-01
2035-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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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 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).
High-resolution bilateral groin ultrasound monitoring
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.
Participants with normal/negative baseline groin ultrasounds - Standard Group
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).
No interventions assigned to this group
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 (n=160).
No interventions assigned to this group
Interventions
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High-resolution bilateral groin ultrasound monitoring
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Royal Brisbane and Women's Hospital
OTHER_GOV
Queensland Centre for Gynaecological Cancer
OTHER_GOV
Responsible Party
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Principal Investigators
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Andreas Obermair, MD
Role: STUDY_CHAIR
Director, Queensland Centre for Gynaecological Cancer Research
Locations
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John Hunter Hospital
Newcastle, New South Wales, Australia
The Royal Darwin Hospital
Darwin, Northern Territory, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
St Andrew's War Memorial Hospital
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Buderim Private Hospital
Buderim, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Mercy Hospital for Women
Heidelberg, Victoria, Australia
Royal Women's Hospital
Parkville, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANVU
Identifier Type: -
Identifier Source: org_study_id
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