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Australian National Vulvar Cancer Trial

PHASE2NOT_YET_RECRUITING

This study is a phase II, 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.

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Study details:

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 1 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. Australian 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 overall outcome of ANVU is a novel, less invasive alternative to vulvar cancer LND associated with significantly less morbidity, without compromising survival.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Females, over 18 years, with histologically confirmed SCC, adenocarcinoma, or melanoma of the vulvar

Clinically stage 1 or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease

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

Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)

SCC of the vulvar 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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2025-04-01

Primary completion: 2027-04-01

Study completion finish: 2029-04-01

Study type

OTHER

Phase

PHASE2

Trial ID

NCT06476639

Intervention or treatment

DIAGNOSTIC_TEST: High-resolution bilateral groin ultrasound monitoring

Conditions

• Vulvar Cancer Stage I
• Vulvar Cancer Stage II
• Lymph Node Metastasis
• Groin Node
• Ultrasound Therapy; Complications

Condition: Vulvar Cancer Stage I, Vulvar Cancer Stage II and more
DIAGNOSTIC_TEST: High-resolution bilateral groin ultrasound monitoring
Newcastle, New South Wales, Australia and more
Sponsor: Queensland Centre for Gynaecological Cancer

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Find a site

Closest Location:

John Hunter Hospital

Research sites nearby

Select from list below to view details:

John Hunter Hospital
Newcastle, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Royal North Shore Hospital
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 and clinical examination every 3 months (n=120).	DIAGNOSTIC_TEST: High-resolution bilateral groin ultrasound monitoring Participants in the Interventional Group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months and a clinical examination every 3 months, for a follow up period of 12 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 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.
NO_INTERVENTION: Participants with normal/negative baseline groin ultrasounds - Standard Group Surgical removal of primary tumour and upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).	Not specified
NO_INTERVENTION: 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.	Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of enlarged clinically palpable groin nodes (groin metastases) in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND.	Determine the incidence of palpable, fixed to skin and histologically positive groin nodes in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND.	12 months after surgery

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Patient Reported Outcomes (PROMs)	Compare PROMS between the groups, as measured by the EuroQoL-5D and FACT-V questionnaires, at baseline, 8 weeks, 6 months, and 12 months.	12 months after surgery
Health Related Quality of Life (HRQL)	Compare HRQL between the groups, as measured by the EuroQoL-5D and FACT-V questionnaires at baseline, 8 weeks, 6 months and 12 months.	12 months after surgery
Pain	Compare pain levels between the groups	12 months after surgery
Adverse events	Compare adverse events between the groups	12 months after surgery
Lower limb lymphoedema	Compare the incidence of lower limb lymphoedema between the groups	12 months after surgery
Cost-effectiveness	Compare cost effectiveness between the groups	12 months after surgery
Disease-free survival	Compare disease-free survival between the groups	12 months after surgery
Overall survival	Compare overall survival between the groups	12 months after surgery
Clinical accuracy of high-resolution serial ultrasound to predict groin lymph node involvement	Determine the diagnostic accuracy of pre-operative, standardised, high-resolution groin ultrasound to identify groin node metastasis	12 months after surgery
Utility of circulating tumour DNA to reliably reflect the presence or absence of positive groin lymph nodes	Assess the role of circulating tumour DNA to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance	Study duration of up to 15 years
Utility of plasma to reliably reflect the presence or absence of positive groin lymph nodes	Assess the role of plasma to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance	Study duration of up to 15 years
Utility of serum to reliably reflect the presence or absence of positive groin lymph nodes	Assess the role of serum to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance	Study duration of up to 15 years
Utility of tumour mutations to reliably reflect the presence or absence of positive groin lymph nodes	Assess the role of tumour mutations to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance	Study duration of up to 15 years

Frequently Asked Questions

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References

Clinical Trials Gov: Australian National Vulvar Cancer Trial