NCT05592639

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

October 13, 2022

Last Update Submit

May 13, 2025

Conditions

Penile CancerInguinal LymphadenopathyMelanoma

Outcome Measures

Primary Outcomes (1)

  • Ability to recruit patients

    Ability to recruit patients at the selected sites (recruitment rate)

    18 months

Study Arms (2)

Videoendoscopic Inguinal Lymphadenectomy

ACTIVE COMPARATOR

Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy

Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

Open Inguinal Lymphadenectomy

OTHER

Removal of inguinal nodes using Open radical inguinal lymphadenectomy

Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

Interventions

Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomyPROCEDURE

Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.

Open Inguinal LymphadenectomyVideoendoscopic Inguinal Lymphadenectomy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, London, NW1 2BU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38600541DERIVED

MeSH Terms

Conditions

Penile NeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesPenile DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Asif Muneer, MD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 25, 2022

Study Start

June 23, 2022

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)