Clinical trial · Interventional
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
NCT06476639CI-TRIAL-00106302ANVUnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Groin Node | — | UNRESOLVED | — |
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Ultrasound Therapy; Complications | — | UNRESOLVED | — |
| Vulvar Cancer Stage I | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Vulvar Cancer Stage II | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-resolution bilateral groin ultrasound monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Participants with normal/negative baseline groin ultrasounds - Intervention Group
- description
- 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).
- interventionNames
- Diagnostic Test: High-resolution bilateral groin ultrasound monitoring
- type
- NO_INTERVENTION
- label
- Participants with normal/negative baseline groin ultrasounds - Standard Group
- description
- 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).
- type
- NO_INTERVENTION
- label
- Participants with suspicious/indeterminate baseline groin ultrasound - Standard Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.