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CompletedInterventional

An international study looking at the treatment of cancer of the penis that has spread to inguinal or pelvic lymph nodes

The InPACT study is an international clinical trial for men with penile cancer that has spread to nearby lymph nodes in the groin or pelvis, but not to other distant organs. Doctors usually use surgery, chemotherapy, and radiotherapy to treat this type of cancer. However, because penile cancer is rare, it is not yet clear which sequence of these treatments produces the best results. Participants in this study will have their treatment order decided by a computer process called randomisation. Some men may have surgery first, while others may receive chemotherapy or a combination of chemotherapy and radiotherapy before or after surgery. The main goal of the study is to see which combination helps men live longer and lowers the chances of the cancer coming back, while carefully monitoring treatment side effects and quality of life.

At a glance

Status
Completed
Sponsor
Institute of Cancer Research
Enrolment target
200
Start
15 May 2017
Estimated completion
31 May 2025

What is this study about?

Penile cancer is a rare type of cancer, and in some cases, cancer cells travel from the penis into nearby lymph nodes in the groin or pelvis. Lymph nodes are small, bean-shaped glands that are part of your immune system. When cancer reaches these nodes, doctors typically recommend a mixture of surgery, chemotherapy, and sometimes radiotherapy.

Because penile cancer does not happen very often, doctors around the world do not yet have strong evidence about the best order to give these treatments. For instance, it is not certain whether giving chemotherapy first helps shrink tumours to make surgery safer, or if operating straight away provides a better outcome.

The InPACT trial brings together cancer specialists from across the UK and other countries to answer these questions. Participants are placed into different treatment groups using a computer program so the results can be compared fairly. Some men will have surgery first, while others will have drug therapy beforehand. Later in the study, depending on what the lab tests show, men may also be offered further surgery or radiotherapy.

By taking part, patients help doctors build clear guidelines for hospitals worldwide. The overall aim is to improve survival rates, reduce the risk of the cancer returning, and help future patients receive the most effective treatment with the fewest possible long-term side effects.

Key takeaways

  • The InPACT trial tests the best sequence of surgery, chemotherapy, and radiotherapy for penile cancer that has spread to nearby lymph nodes.
  • A computer decides your treatment order to ensure fair comparison between groups.
  • The study aims to discover which approach best controls cancer and improves long-term survival.
  • Participation involves treatments given in hospital followed by regular long-term follow-up visits.
  • Joining is completely voluntary, and you may leave the study at any time without affecting your NHS care.

Who may be eligible?

This trial is open to men aged 18 and over who have been diagnosed with squamous cell carcinoma of the penis (the most common type of penile cancer). To be eligible, the cancer must have spread to the lymph nodes in the groin or pelvis, but it must not have spread to distant parts of the body such as the lungs, liver, or bones.

Men taking part need to be well enough to manage day-to-day activities and handle treatment, which doctors check using a fitness score. Good kidney and liver function are also required, as confirmed by standard blood tests, to ensure the body can safely process chemotherapy drugs.

Men cannot join this study if they have rare non-squamous forms of penile cancer, cancer that started in the urethra, or cancer that has already spread widely across the body. You also cannot join if you have already had chemotherapy or radiotherapy for this cancer, or if you have had another active cancer requiring treatment in the last three years (apart from common, non-melanoma skin cancers). Men who are sexually active must agree to use reliable contraception during the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am a man aged 18 years or older.
  2. I have been diagnosed with squamous cell penile cancer.
  3. The cancer has spread to lymph nodes in my groin or pelvis.
  4. The cancer has not spread to distant parts of my body, like my lungs or liver.
  5. I have not had previous chemotherapy or radiotherapy for this cancer.
  6. I feel reasonably well and can look after myself day-to-day.
Answer every question to see your result.

What does participation involve?

Taking part begins with a detailed check-up, including scans (such as CT, MRI, or PET scans), physical checks of your groin, and routine blood tests to see if the trial is right for you. If you join, a computer program will assign your treatment plan. Depending on your group, you may receive chemotherapy through a drip in hospital over several weeks, undergo surgery to remove the affected lymph nodes and tumour, or receive radiotherapy aimed at your pelvis. The active treatment phase typically lasts several months. After your treatment is complete, you will have regular clinic visits, blood tests, and scans over a number of years so the medical team can closely track your recovery, health, and wellbeing.

Potential risks and benefits

Taking part may mean receiving treatments like chemotherapy before surgery that could help shrink the cancer, and your health will be monitored very closely by specialist teams throughout the study. However, there is no guarantee this approach will work better than standard care. You may experience known side effects from chemotherapy (such as tiredness, sickness, hair thinning, and a higher risk of infection), surgery (such as pain, wound healing issues, or fluid swelling in the legs called lymphoedema), or radiotherapy. Taking part is completely voluntary. You can choose to leave the study at any time without giving a reason, and your regular NHS medical care will continue as normal.

Locations (6)

  • St George’s Hospital
    Approximate
    London, England
  • The Royal Marsden Hospital
    City only
    Sutton, England
  • Leicester General Hospital
    Approximate
    Leicester, England
  • Norfolk and Norwich University Hospital
    Approximate
    Norwich, England
  • Velindre Hospital
    Approximate
    Cardiff, Wales
  • Morriston Hospital
    Unverified
    Swansea, Wales

Common questions

What is randomisation and why is it used?

Randomisation is a method where a computer randomly allocates you to a treatment group. This prevents bias and ensures the groups are balanced, allowing doctors to fairly compare which treatment sequence works best.

Can I choose which treatment I receive?

No. To ensure the study results are fair and scientific, treatment plans must be allocated randomly by computer. However, your doctor will only enroll you if all possible options are medically safe and suitable for you.

Will taking part in this trial cost me anything?

No. The trial treatments, tests, and scans are provided through the NHS. Some hospitals may also offer help with travel costs for extra visits.

Why do I need to use contraception during the trial?

Chemotherapy and radiotherapy can damage sperm and harm an unborn baby. Men who are sexually active with a partner who could become pregnant must use reliable contraception during treatment and for a set period afterwards.

What happens if I change my mind later?

You are free to stop participating at any time. Leaving the trial will not affect your relationship with your doctors or the quality of your NHS treatment.

How to find out more

Stephanie Burnett

Always speak to your GP or specialist before deciding to take part in a study.

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