All cancer treatments available today have been proven in clinical trials. Clinical trials are research studies that test the idea that a new treatment or other healthcare intervention is better than the existing drug or practice. While it may be natural to assume that the new treatment is better, this may not be the case. It may be worse in terms of its effect on the cancer, its side effects, costs, or inconvenience to you. On the other hand, it might truly be better and become established as the new standard of care.
This section explains how trials are run, how you might take part in a clinical trial and how a trial might help you.
Question 1. What is a clinical trial?
A clinical trial is an experiment that tests an idea. It could be an idea about how to give a treatment, for example, if a new treatment is safe or how well it works. The treatment being tested can be a drug, a new way of giving radiation or performing an operation, or something as simple as a different way of caring for patients. Sometimes the clinical trial tests a combination of drugs or treatments that have not been tested before to see if two treatments combined are better than one.
At any time there are many trials testing new cancer treatments occurring all around the world. These trials cover many different types of cancer and include thousands of patients. All of the drugs we can use to treat kidney cancer have been tested in clinical trials at some point. In kidney cancer, researchers are also working to determine which treatments work best for which patients.
Every new drug has to be rigorously tested and must pass through pre-clinical research and several “phases” of clinical trials before it can be prescribed to patients. This process can take many years from start to finish.
Question 2. Why can’t I just take the new treatment?
We all want the best possible treatment for our family and ourselves. When a “new” medication is mentioned in the newspaper, or on the TV, we take interest, especially if someone we love is currently living with cancer. More generally we all hope that better treatment options might be available to us should the need ever arise. One question that people often ask is “why can’t I just take the new treatment?”
What treatment is offered in a clinical trial depends on the phase of the clinical trial, and the design of the trial. In phase I and some phase II trials, the new treatment is usually the only one given. In some phase II trials and almost all phase III trials, you might be “randomised” to take either the standard treatment or the new treatment.
Why do clinical trials randomise treatments?
“Randomised” means that once you choose to take part in the trial, and the team caring for you has checked that you fit all the criteria required for the trial, neither you nor your doctor has a choice of what treatment you take. While not as crude as flipping a coin, a computer randomly assigns patients to the different treatments being tested.
Will I get the new treatment either way? (Is there cross-over?)
Some well-designed trials allow patients to “cross-over” to the new treatment from the standard treatment if/when it fails. This allows the drug to be well tested, but also offers every patient the opportunity to benefit from the novel therapy.
What if I don't receive the newer treatment?
While the quality of care provided by your doctor will be the highest they can deliver within your health care system, patients on clinical trials routinely experience an even higher quality of care than patients not on clinical trials. This is likely because they have the doctors and nurses watching them so closely, that problems get discovered and addressed even faster than in people not on clinical trials.
Question 3. Is a clinical trial right for me?
A clinical trial can be a very good option for treatment if you are suffering cancer. The most obvious reason for considering a clinical trial is obviously to find a treatment that will be best for you. Many patients join a trial hoping that the treatment they can get on a trial is better than the standard that is currently available. However it’s important to remember that you may or may not benefit personally from being part of a trial. You may not get the “new” treatment, or it may not work for you, or you may not tolerate whichever treatment you are assigned.
You can expect some things if you choose to take part in a clinical trial. Being treated on a clinical trial is likely to result in close observation and care from a highly skilled and specialized team. Your care taking the standard treatment on a clinical trial may indeed be better than in routine clinical practice. In addition, you will experience a great deal of personal satisfaction from having contributed to the body of human knowledge, of being one of the people that helps test new ideas for the treatment of cancer. Clinical trials are essential to find out more about diseases and how to treat them. So if you do take part in a trial, any information collected during the trial will inform decisions about the best way to treat future patients.
- An up-to-date assessment of your condition.
- Detailed information about the trial, including what treatment is being tested and what taking part could mean for you.
- What alternative treatments or trials are available.
Question 4. Am I right for a clinical trial?
It is not always possible to join a trial, even if you want to. When researchers design clinical trials, they usually have a strict set of rules to help them choose who can take part. For example, If a patient’s tumours are too small, it can make it hard to tell if the treatment is working or not. If patients are too sick then it may not be possible to safely give the treatment for fear of side effects.
- your general health is not good enough (you are too unwell)
- you have had previous treatment for your kidney cancer that could affect the results of the trial
- you have other diseases (e.g. diabetes mellitus or auto-immune diseases) which could make you more likely to have side-effects or affect the results of the trial
- you have had another kind of cancer at some time in the past
Question 5. What are the benefits of taking part in a trial?
When deciding if you want to take part in a trial, it is important to realise that the new treatment might work for you, but it might not. Depending upon the trial, you might be randomised to a control arm to receive the standard treatment. When there are two arms of a trial, as the patient you cannot simply choose which treatment you would prefer.
- You will be seen by doctors and nurses who are experts in treating your condition, in hospitals that have the best facilities.
- The health of people who take part in clinical trials is usually monitored more closely than the health of patients who do not take part in trials.
- You are making a valuable contribution to medical research.
- You are taking control of the treatment of your illness.
Question 6. What are the risks of taking part in a clinical trial?
There are several risks to consider before joining a clinical trial.
The new treatment might cause unpredictable or serious side effects. In some cases, these can be permanent. This is particularly relevant if you want to join a trial that is the first to test a drug in humans (a phase I trial). Despite the hopes of the doctors running the trial, the new treatment might not work as well as the treatments that are already available, or it might not work at all for you.
There may be financial costs to consider too, like travel and accommodation costs, or the cost of you or a caregiver taking time off work to go to the trial clinic. You will not be paid money to take part in a clinical trial, and likewise while the trial should not place undue costs on you, it is very rare for the trial to reimburse any costs incurred. If you are worried about taking part in a clinical trial, you should talk to your doctor. To help you gather the facts you need to make your decision, we have written a list of questions to ask your doctor. These can be found here.
Question 7. Why can’t I get on to a clinical trial?
Clinical trials need patients to take part to be successful. Unfortunately, the number of people taking part in trials is low in many countries. An American study found that about 1 in 3 trials close early because they cannot find enough people to take part. Conversely it can be hard to find a clinical trial that is useful to you.
- no suitable trial is available
- not being told about the trial by their doctor
- worries about being given placebo treatment (placebos are rarely used in kidney cancer trials)
- logistical problems (e.g. not being able to get to a treatment centre easily or not being able to take extra time off work)
- the trial has very strict rules for who can take part and they are not eligible
- simply not wanting to take part.
Question 8. Blind? What do all these words and phrases mean?
In the following we are going to explain words and phrases often used in the context of clinical trials. Many of those are also used by clinical researchers and within descriptions of clinical trials.
Just click on the word to get the explanation:
If a cancer has been completely removed during an operation, there is still a chance that it can recur, due to tiny seeds from the cancer that spread. Adjuvant therapy adds to surgery, but trying to prevent this process and reduce the chance of a cancer coming back.
Best supportive care
This means a patient receives treatment to alleviate their symptoms, but no specific treatment against the cancer. This may include pain relief and other palliative measures.
Blinding means concealing the allocation of which treatment the patient is taking. The power of persuasion is very strong, and people can often feel much better for taking a treatment, any treatment. In many trials patients are therefore “blinded” to which treatment they are taking.
Patients who wish to take part in a clinical trial must be extremely well informed about all aspects of the trial. Consent is the permission given by the patient to their doctor to take part in the trial. Patients need to know a lot about the trial before they can decide whether or not to take part; they must be well informed. Informed consent is important for every medical intervention (from a simple blood test through to brain surgery) and is extremely important for clinical trials.
The group of patients who take the standard therapy, or if no therapy is proven useful in this situation, then patients may take a placebo, or best supportive care.
Neither the doctor nor the patient knows if they are in the treatment or control group.
This is the ‘go-to’ treatment that most people would take first when a disease is diagnosed. It is often the strongest and most effective treatment.
Both the doctor and the patient know which treatment group the patient is in.
PICF - Patient information and consent form
The document that describes all the processes, procedures, side-effects and support available and form the legal basis of the agreement between the patient and their doctor to take the clinical trial. There is often little information about a new treatment available to the public, and so this document is also the most important source of information about the trial. All patients will receive a copy of the PICF and should carry it with them to assist with their care from other health care professionals.
It is important to remember that:
- your participation is entirely your choice
- not participating or leaving the trial early will have no negative impact on the standard of care you receive
- any information you give the trial team will remain private
- Even if you have signed a declaration of consent, you still have the right to leave the trial at any time if you change your mind. If you decide to leave the trial, your doctor will recommend other treatment (if available).
A placebo is a dummy treatment that contains no active drug. It might be a capsule or pill, it might be a bag of saline. Sometimes just thinking you are being treated can make you feel better. This is a common psychological phenomenon called the placebo effect. Because there are now effective treatments for kidney cancers, placebos are very rarely used in kidney cancer trials. If you are thinking of taking part in a trial with a placebo group, you need to think about how you will feel if you find out at the end of the trial that you were given the placebo. Some trials give the new treatment to the placebo group after the trial has ended, or swap the treatment and placebo groups during the trial. So even if you are in the placebo group at first, you might still get the new treatment later on. When you ask about a clinical trial, be sure to ask about whether any patients will receive a placebo.
The process of randomly choosing which treatment group a patient is put into. This is normally done by a computer.
Before being allowed to start a trial, patients are always asked to undergo “screening” to ensure that their disease and general health is well understood and matches the criteria of the trial. Screening might be as simple as a blood test, or could include MRI, CT or PET scans. Unfortunately sometimes a biopsy of the cancer is also required, and even if you have only had scans recently, you might need to repeat these scans again.
This is the treatment given to patients if the first-line therapy does not work for them. If the second-line therapy doesn’t work, then a third-line therapy will be tried, then a fourth-line therapy, and so on.
The doctor knows which treatment group the patient is in, but the patient does not.
To assess whether treatment is helping patients or not, scans are taken at intervals to find out if patients’ cancers are bigger, smaller or the same size. Some clinical trials demand that a spot of cancer in a particular part of the body is measured at many times during the trial to assess treatment. These staging, and re-staging scans are therefore very important to assess the effectiveness of the treatment and to advise patients whether to stay on treatment or take something else.
The group of patients who take the new treatment being tested.
Question 9. How do I find out more about clinical trials?
There is a lot of useful information about clinical trials available online and through kidney cancer patient organisations. Local organisations may best know which trials are open in your region. For a list of kidney cancer organisations, see here.
- the healthcare system in your country (e.g. the NHS Choices website in the UK)
- teaching hospitals
- medical research charities
- patient groups
- research programmes.
The following websites have some useful general information about clinical trials.
- the European Organisation for Research and Treatment of Cancer patient brochure is available in English, French and Dutch. Other languages will be added in the future.
- the NHS Choices website: Clinical trials and medical research
- The American Cancer Society website: Clinical Trials
Question 10. How do I find a clinical trial for ME?
This website has a list of major immuno-oncology (IO) trials for kidney cancer.
To find out more about kidney cancer trials that might be right for you, you could try the following sources and ideas for more information.
- Ask one of your doctors if they know of any trials that are suitable for you.
- Ask about trials that might be available in other hospitals that you could travel to.
- Call the hospital and ask to speak to “cancer clinical trials” or “oncology clinical trials”, then ask to speak to the “clinical trial coordinator” for kidney cancers or genitourinary cancers
- Contact kidney cancer patient organizations in your country, or international organisations like the International Kidney Cancer Coalition.
- Investigate country-specific or regional urology or kidney research networks or associations
- Search clinical trial online databases; for example
- National Cancer Institute
- EU Clinical Trials Register
- EMA Clinical Trials Database
- Please note: These websites may not have information about the precise hospital that is running the trial; but once you have identified the general location of trial centres from these websites you can use the Internet to find the specific hospital, and then use the tips above to identify the right person to speak with within that hospital.