Queensland Centre for Gynaecological Cancer
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.
Vulvar Cancer Stage I
Vulvar Cancer Stage II
Lymph Node Metastasis
Groin Node
Ultrasound Therapy; Complications
High-resolution bilateral groin ultrasound monitoring
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 240 participants |
| Masking : | NONE |
| Primary Purpose : | OTHER |
| Official Title : | A Phase II Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer |
| Actual Study Start Date : | 2025-04 |
| Estimated Primary Completion Date : | 2027-04 |
| Estimated Study Completion Date : | 2029-04 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
Not yet recruiting
The Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Not yet recruiting
The Royal Darwin Hospital
Darwin, Northern Territory, Australia, 0810
Not yet recruiting
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Not yet recruiting
Mater Hospital
Brisbane, Queensland, Australia, 4000
Not yet recruiting
St Andrew's War Memorial Hospital
Brisbane, Queensland, Australia, 4000
Not yet recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Not yet recruiting
Buderim Private Hospital
Buderim, Queensland, Australia, 4556
Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not yet recruiting
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Not yet recruiting
Mercy Hospital for Women
Heidelberg, Victoria, Australia, 3084
Not yet recruiting
Royal Women's Hospital
Parkville, Victoria, Australia, 3052
Not yet recruiting
St John of God Hospital
Subiaco, Western Australia, Australia, 6904