Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
This study is about improving treatment for a cancer called germ cell tumour, which can start in different parts of the body, including the testicles or ovaries. The standard treatment is a type of chemotherapy called BEP. While BEP works very well for many, it's less effective for those with intermediate or high-risk disease. Researchers are testing a new approach called 'accelerated BEP'. This involves giving the same chemotherapy drugs but on a quicker schedule. The main aim is to find out if this faster treatment is more successful than the standard one in curing intermediate and high-risk germ cell tumours, while still being safe for patients.
At a glance
What is this study about?
If you or someone you know has been diagnosed with a germ cell tumour, this study might be of interest. Germ cell tumours are a type of cancer that can develop from cells that normally go on to form sperm or eggs. While they often start in the testicles or ovaries, they can also appear in other areas like the chest or abdomen. For many people, a chemotherapy treatment called BEP (which uses three drugs: Bleomycin, Etoposide, and Cisplatin) works very well.
However, for some individuals, particularly those whose cancer is considered 'intermediate' or 'poor-risk' – meaning it's more widespread or aggressive – the standard BEP treatment isn't always as effective. While treatments for germ cell tumours have improved significantly over the years, doctors are always looking for ways to make them even better, especially for those with more challenging forms of the disease. Previous attempts to improve initial chemotherapy haven't really worked out well and sometimes caused more side effects.
This new study is exploring a different approach. Instead of changing the drugs, it changes how often they are given. The standard BEP treatment is usually given every three weeks. In this study, doctors are looking at an 'accelerated' BEP, where two of the main drugs (Cisplatin and Etoposide) are given every two weeks instead. The main goal is to see if giving these drugs more frequently can improve the chances of curing the cancer for people with intermediate or poor-risk germ cell tumours, compared to the standard three-weekly schedule.
Key takeaways
- This study compares a faster (accelerated) chemotherapy with the standard treatment.
- It's for people with intermediate or poor-risk germ cell tumours.
- The goal is to find out if the accelerated treatment works better.
- Participation involves being randomly assigned to one of two treatment groups.
- You'll receive regular medical care and monitoring throughout the study.
Who may be eligible?
This study is for people generally aged between 11 and 50 years old. You would need to have been diagnosed with a germ cell tumour that has spread to other parts of the body, or a tumour that started outside of the testicles or ovaries.
Crucially, your cancer must be classified as 'intermediate' or 'poor-risk'. This classification helps doctors understand how serious the cancer is and how likely it is to respond to standard treatment. To be considered, your body must also be working well enough to handle chemotherapy, including your bone marrow (which makes blood cells), liver, and kidneys. You should also be well enough to carry out most daily activities without too much difficulty. The study doctors will perform tests to check these things.
There are also a few reasons you might not be able to join. For example, if you've had other types of cancer (unless it was a very minor skin cancer or another cancer treated a long time ago with no signs of returning), or if you've already had chemotherapy or radiotherapy for your current germ cell tumour (with a few exceptions for specific types of seminoma), you wouldn't be eligible.
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.
- Are you between 11 and 50 years old?
- Do you have a germ cell tumour that has spread, or a tumour outside the testicles/ovaries?
- Has your cancer been classed as 'intermediate' or 'poor-risk'?
- Are your body's main organs (like liver and kidneys) generally working well?
- Have you not had previous chemotherapy or radiotherapy for this cancer (with some specific exceptions)?
What does participation involve?
If you decide to take part in this study, you will receive either the standard BEP chemotherapy or the accelerated BEP chemotherapy. The study is designed to be a comparison, so you will be randomly assigned to one of these two groups – like flipping a coin. Both treatments involve receiving the three chemotherapy drugs (Bleomycin, Etoposide, Cisplatin) and supportive medicines like Pegylated G-CSF or Filgrastim, which help protect your white blood cells.
Each cycle of chemotherapy will involve visits to the hospital for treatment. The standard treatment is given every three weeks, while the accelerated treatment gives some drugs every two weeks. You will have regular check-ups, blood tests, and scans throughout your treatment to monitor your health and how the cancer is responding. The total length of the chemotherapy treatment is typically around 12 weeks (4 cycles), but follow-up will continue for several years to track your long-term health and the cancer's progress.
Potential risks and benefits
Locations (56)
- Kaiser Permanente Downey Medical CenterVerified postcodeDowney, United States· Recruiting
- Loma Linda University Medical CenterVerified postcodeLoma Linda, United States· Recruiting
- Miller Children's and Women's Hospital Long BeachVerified postcodeLong Beach, United States· Recruiting
- Los Angeles General Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- USC / Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Recruiting
- Lucile Packard Children's Hospital Stanford UniversityVerified postcodePalo Alto, United States· Recruiting
- Stanford Cancer Institute Palo AltoVerified postcodePalo Alto, United States· Recruiting
- Rady Children's Hospital - San DiegoVerified postcodeSan Diego, United States· Recruiting
- Ann and Robert H Lurie Children's Hospital of ChicagoVerified postcodeChicago, United States· Recruiting
- University of IllinoisVerified postcodeChicago, United States· Recruiting
- Advocate Children's Hospital-Oak LawnVerified postcodeOak Lawn, United States· Recruiting
- Advocate Children's Hospital-Park RidgeVerified postcodePark Ridge, United States· Recruiting
Common questions
What is a germ cell tumour?
It's a type of cancer that grows from cells that would normally develop into sperm or eggs. While they often start in the testicles or ovaries, they can appear in other places too.
What is 'accelerated' chemotherapy?
It means giving the chemotherapy drugs on a quicker schedule than usual, to see if it makes the treatment more effective.
Will I know if I'm getting the standard or accelerated treatment?
No, you will be randomly assigned to one of the two groups, and neither you nor your doctors will know which treatment you are receiving until after the study is over. This helps ensure fair results.
What are the main drugs used in this treatment?
The main chemotherapy drugs are Bleomycin, Etoposide, and Cisplatin. You'll also receive medicines like Pegylated G-CSF or Filgrastim to help with side effects.
How long will the treatment last?
The chemotherapy part of the study typically lasts around 12 weeks, but you'll have follow-up appointments for several years to monitor your health.
How to find out more
P3BEP Trial Coordinator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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