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VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer (VELRAD)

Primary Purpose

Penile Cancer, Inguinal Lymphadenopathy, Melanoma

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Penile Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Videoendoscopic Inguinal Lymphadenectomy

Open Inguinal Lymphadenectomy

Arm Description

Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy

Removal of inguinal nodes using Open radical inguinal lymphadenectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 13, 2022
Last Updated
May 10, 2023
Sponsor
University College, London
Collaborators
The Christie NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05592639
Brief Title
VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer
Acronym
VELRAD
Official Title
Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
The Christie NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Cancer, Inguinal Lymphadenopathy, Melanoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Videoendoscopic Inguinal Lymphadenectomy
Arm Type
Active Comparator
Arm Description
Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy
Arm Title
Open Inguinal Lymphadenectomy
Arm Type
Other
Arm Description
Removal of inguinal nodes using Open radical inguinal lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
Intervention Description
Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.
Primary Outcome Measure Information:
Title
Ability to recruit patients
Description
Ability to recruit patients at the selected sites (recruitment rate)
Time Frame
18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anvi Wadke
Phone
+442079074687
Email
A.wadke@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Stanley Tang, BMBS
Phone
+442034567890
Email
Stanley.tang2@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asif Muneer, MD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anvi Wadke
Email
sig.velrad@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Asif Muneer, MD
First Name & Middle Initial & Last Name & Degree
Stanley Tang, BMBS

12. IPD Sharing Statement

Learn more about this trial

VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

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