Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476639
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-17
Brief Title:
Australian National Vulvar Cancer Trial
Sponsor:
Queensland Centre for Gynaecological Cancer
Organization:
Queensland Centre for Gynaecological Cancer
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANVU
Brief Summary:
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
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 ie 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 eg 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 2D3D 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
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 ie 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 eg 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 2D3D 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None