Penile CancerVELRADNCT05592639
VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer
A study testing Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy in people with Penile Cancer and Inguinal Lymphadenopathy, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Cancer, Inguinal Lymphadenopathy, Melanoma
- What is being tested?
- Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People requiring inguinal lymphadenectomy i.e.
- Patients with squamous cell carcinoma or mucosal melanoma of the penis > T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy
- Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB
- Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy
- Small volume palpable inguinal lymph nodes (< 2 cm on CT) not fixed to skin
- Age > 18 years
Who cannot join
- Unfit for surgery
- People unlikely to benefit from lymphadenectomy because of advanced cancer
- Those with palpable inguinal lymph nodes fixed to skin or adjacent structures
- Does not want to participate in the trial or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
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.
Read the detailed description
There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes.
As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures.
VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised
- Conditions
- Penile Cancer, Inguinal Lymphadenopathy, Melanoma
- Being tested
- Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
- Medical subject headings
- Penile Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomyProcedure or surgery
Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Videoendoscopic Inguinal Lymphadenectomy | Active comparator | Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy Receives: Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy |
| Open Inguinal Lymphadenectomy | Other | Removal of inguinal nodes using Open radical inguinal lymphadenectomy Receives: Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to recruit patients
Ability to recruit patients at the selected sites (recruitment rate)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start23 Jun 2022
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Asif Muneer, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592639
- Sponsor's protocol ID
- 130062
- Acronym
- VELRAD
- Status last verified
- May 2025
- First submitted
- 13 Oct 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang S, Akers C, Alnajjar H, Ayres B, Baldini C, Embleton-Thirsk A, Gurusamy K, Hadway P, Kumar V, Lau M, Nigam R, Pang K, Parnham A, Pizzo E, Ranieri V, Rees R, Sangar V, Wadke A, Williams N, Muneer A. A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD). Pilot Feasibility Stud. 2024 Apr 10;10(1):61. doi: 10.1186/s40814-024-01474-8.
PubMed 38600541
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05592639
- Acronym / sponsor ID
- VELRAD / 130062
- Conditions
- Penile Cancer, Inguinal Lymphadenopathy, Melanoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes.
As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures.
VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoendoscopic Inguinal Lymphadenectomy | Active comparator | Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomyRemoval of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy |
| Open Inguinal Lymphadenectomy | Other | Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomyRemoval of inguinal nodes using Open radical inguinal lymphadenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People requiring inguinal lymphadenectomy i.e.
- Age > 18 years
Key exclusion criteria (4 listed)
- Unfit for surgery
- People unlikely to benefit from lymphadenectomy because of advanced cancer
- Those with palpable inguinal lymph nodes fixed to skin or adjacent structures
- Does not want to participate in the trial or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomyIntervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes. | Procedure or surgery | Open Inguinal Lymphadenectomy, Videoendoscopic Inguinal Lymphadenectomy |
Primary outcome
Ability to recruit patients
Time frame: 18 months
Ability to recruit patients at the selected sites (recruitment rate)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 38600541Tang S, Akers C, Alnajjar H, Ayres B, Baldini C, Embleton-Thirsk A, Gurusamy K, Hadway P, Kumar V, Lau M, Nigam R, Pang K, Parnham A, Pizzo E, Ranieri V, Rees R, Sangar V, Wadke A, Williams N, Muneer A. A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD). Pilot Feasibility Stud. 2024 Apr 10;10(1):61. doi: 10.1186/s40814-024-01474-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asif Muneer, MD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy in people with Penile Cancer and Inguinal Lymphadenopathy, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to recruit patients (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.