A study comparing 2 ways to remove lymph nodes during surgery for penile cancer (VELRAD)
Cancer type:
Status:
Phase:
This study is comparing 
with open surgery to remove in the groin during surgery for penile cancer.
It is also open to people with cancer of the who need to have the lymph nodes in the groin removed.
More about this trial
One of the main treatments for penile cancer is surgery. During surgery, the surgeon might remove the nearby lymph nodes. They do this if there is cancer in the lymph nodes or they think there might be.
The is to remove the lymph nodes through a cut (incision) in the groin. This is open surgery. Doctors know what the complications of open surgery are, for example swelling in the legs or genitals (lymphoedema). These can affect between 2 and 6 people out of every 10 who have open surgery.
Another way to do the surgery is video endoscopic inguinal lymphadenectomy (VEIL). This is a type of surgery called keyhole surgery. For keyhole surgery, the surgeon makes a small hole in the groin and uses a flexible tube to remove the lymph nodes.
It isn’t known whether VEIL has fewer or more complications than open surgery. To find this out researchers need to do a large comparing the 2 different surgeries.
Before they can do this trial, they need to know if it is possible to do so. This is a feasibility study.
In this feasibility study half the people will have open surgery to remove their lymph nodes. And the other half will have VEIL.
The aims of this feasibility study are to find out:
- whether it is possible to do a large randomised clinical trial comparing open surgery with VEIL
- more about the side effects and complications of VEIL
- how the 2 different surgeries affect
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have cancer of the penis that has grown into the spongy erectile tissue and might have spread into the urethra or surrounding organs such as the prostate, scrotum or pubic bone and the cells look a bit normal or abnormal
- have a squamous cell penile cancer or a
mucosal melanoma of the penis - need to have surgery to remove the lymph nodes from the groin. You could also join if you have a cancer of
urethra that needs surgery to remove the lymph nodes. - are over 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- are not able to have surgery
- are unlikely to benefit from surgery to remove the lymph nodes. Your doctor will know if this is the case.
- have lymph nodes the doctor can feel but they are attached to the skin or to other structures such as muscle. Your doctor will know about this.
- have any other medical condition, mental health problem or social situation that could affect you taking part
Trial design
This is a feasibility study. The team need 50 people to join.
It is a randomised study. You are put into 1 of 2 groups. Neither you nor your doctor chooses which group you are in. The 2 groups are removal of the lymph nodes using:
- video endoscopic inguinal lymphadenectomy (VEIL)
- open surgery
Video endoscopic surgery
You have video endoscopic surgery as keyhole surgery. The surgeon makes a small hole in the groin. A small flexible tube is put through the hole. Through this tube the surgeon is able to see the lymph nodes and remove them.
Open surgery
This is the standard way to remove the lymph nodes. The surgeon makes a cut about 10cm long in the groin to take out the affected lymph nodes.
For both types of surgery you have a .
Study interview
When your doctor tells you about the study you might be invited to take part in an interview. You can take part in the interview whether you decide to join the study or not.
A member of the team will tell you more about the interview.
Quality of life
You fill in questionnaires before having surgery and then after surgery at:
- 1 week
- 1 month
- 3 months
- 6 months
The questions ask about:
- your general health and well being
- what you are able to do
- side effects and complications
- whether you have had to visit your GP or another health professional as well as your clinic appointments for follow up after surgery
These are quality of life questionnaires.
Hospital visits
You see the doctor before taking part. This is to talk to you about the study and to take a .
After your surgery you see the doctor at:
- 1 week
- 1 month
- 3 months
- 6 months
This is to see how you are and if there are any side effects or complications from the surgery.
You have a CT scan at 3 months.
You might have another scan at 6 months. Your doctor will tell you if you do.
Side effects
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
You might have side effects or complications from surgery to remove the lymph nodes. Possible problems include:
- swelling of the legs and genitals
- blood clot
- problems getting an erection
Whether having VEIL causes fewer or more side effects than open surgery isn’t well known.
We have information about possible problems after having surgery for penile cancer.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Asif Muneer
Supported by
University College London (UCL)
National Institute for Health Research (NIHR)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
