Melanoma Clinical Trial
— VELRADOfficial title:
Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
NCT number | NCT05592639 |
Other study ID # | 130062 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 23, 2022 |
Est. completion date | August 1, 2024 |
Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. People requiring inguinal lymphadenectomy i.e. 1. Patients with squamous cell carcinoma or mucosal melanoma of the penis > T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy 2. Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB 3. Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy 4. Small volume palpable inguinal lymph nodes (< 2 cm on CT) not fixed to skin 2. Age > 18 years Exclusion Criteria: 1. Unfit for surgery 2. People unlikely to benefit from lymphadenectomy because of advanced cancer 3. Those with palpable inguinal lymph nodes fixed to skin or adjacent structures 4. Does not want to participate in the trial or unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | Norfolk and Norwich University Hospitals NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to recruit patients | Ability to recruit patients at the selected sites (recruitment rate) | 18 months |
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