A phase II trial of an individualized treatment strategy for patients with metastatic non-clear cell renal carcinoma
This research study, called a Phase II trial, is looking for better ways to treat a specific type of kidney cancer called 'non-clear cell renal carcinoma' when it has spread to other parts of the body. Doctors want to find out if giving treatments that are tailored to each patient works well. They're testing several different medicines, including Tafinlar, Tarceva, KEYTRUDA, and others, to see how much they can shrink the cancer and how long people can go without their cancer getting worse. The study will also look at side effects, how the treatment affects daily life, and how long people live. This is an important step to developing more effective and personalised care for patients with this challenging cancer.
At a glance
What is this study about?
This study is a Phase II clinical trial. This means it's one of the earlier stages of testing new treatments, following initial safety checks, to see if they work well for a specific condition. In this case, the condition is advanced kidney cancer, specifically a type called 'non-clear cell renal carcinoma' that has spread to other parts of the body. This type of kidney cancer can be challenging to treat, so doctors are always looking for more effective options.
The main idea behind this study is to see if a 'personalised' treatment approach works better. This means that instead of a standard treatment for everyone, doctors might choose a specific medicine or combination of medicines based on a deeper understanding of each patient's cancer. The study is using many different established cancer drugs, such as Tafinlar, Tarceva, KEYTRUDA, and others. The aim is to see which of these, when given in a tailored way, can shrink the cancer and keep it under control for as long as possible.
The researchers will be closely watching two main things: first, how many patients see their cancer shrink (this is called the 'overall response rate'), and second, how long it takes before the treatment stops working or the cancer starts to grow again (this is called 'time-to-treatment failure'). They will also be looking at other important aspects like how long people live, if their cancer stays stable, the side effects experienced, and how treatments affect a patient's quality of life.
Key takeaways
- Tests new, personalised treatments for advanced non-clear cell kidney cancer.
- Aims to find out which medicines shrink the cancer and control its growth.
- Involves several different established cancer drugs.
- Looks at side effects and how treatment impacts patients' lives.
- Open to adults aged 18 and over, both men and women.
Who may be eligible?
To be part of this study, you usually need to meet certain conditions. For this particular study, it's open to adults aged 18 years and older, with no upper age limit. The study welcomes both men and women.
The most important requirement is that you must have been diagnosed with 'metastatic non-clear cell renal cell carcinoma'. 'Metastatic' means the cancer has spread from your kidney to other parts of your body. 'Non-clear cell' refers to a specific type of kidney cancer that doctors identify under a microscope.
There will be other detailed medical criteria that your doctor will check, such as your general health, other medical conditions you might have, and any previous treatments you've received. These checks are important to make sure the study is safe for you and that the results will be meaningful.
- Are you 18 years old or older?
- Have you been diagnosed with kidney cancer that is not 'clear cell' type?
- Has your kidney cancer spread to other parts of your body?
- Are you able to attend regular hospital visits for treatment and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given one of several medicines, which could be in capsule, tablet, or infusion (given through a drip) form, depending on what your doctors decide is best for you based on the study's approach. You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to monitor for any side effects.
During these visits, you might also be asked to fill out questionnaires about how you are feeling and how the treatment is affecting your daily life. The exact number of visits and the total length of time you'd be in the study will depend on how your cancer responds to the treatment. Typically, treatment will continue for as long as it is working and you are tolerating it well. After the treatment period, you would likely have a follow-up period where doctors continue to monitor your health.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What type of cancer is this study for?
This study is for a specific type of kidney cancer called 'non-clear cell renal carcinoma' that has spread to other parts of the body.
What does 'personalised treatment' mean in this study?
It means doctors will try to choose the best medicine for you based on your individual cancer, rather than a single treatment for everyone.
Will I definitely get one of the new medicines?
Yes, if you join this study, you will receive one of the specific cancer medicines being tested, chosen by the study doctors for your individual case.
What are the main things the doctors are looking for?
The main goals are to see how much the cancer shrinks and how long the treatment keeps the cancer under control before it starts to grow again.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and it won't affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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