Clinical trials provide individuals with cancer access to the newest types of treatment. These trials are studies of new therapies to determine whether a medication is safe and effective. Generally, clinical trials compare new treatment with current therapies. Clinical trials may assess new medications and new combinations of treatments. This may include combinations of medications, and combinations of radiation, biological therapy, chemotherapy, and targeted therapy.
Clinical trial participation is often offered to people with high-risk stage 2, stage 3, or stage 4 melanoma. People with persistent or recurrent melanoma may also be offered clinical trial participation. There may be clinical trials in melanoma available in your area.
By taking part in a clinical trial, you could be among the first to benefit from a new treatment. Although there is no guarantee of the outcome, the treatment being tested may prove to be as effective or more effective than the standard treatment available for your cancer at this time. Talk to your doctor if you are interested in being part of a clinical trial.
Search for Canadian Clinical Trials
Canadian Cancer Trials
This is a valuable bilingual site for current Canadian clinical trials. It was established by the Federal Government’s organization ‘Canadian Partnership Against Cancer’. You can request to be notified when a clinical trial becomes available for a particular cancer or location.
National Cancer Institute Clinical Trials
This site provides easy-to-understand information about clinical trials going on around the world – many of them in Canada – and includes full text publications and links to many other relevant sites. Information is tailored for patients or for health professionals.
Phases of Clinical Trials
“Clinical trials for new cancer treatments are tested in series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. During the early phases (phases 1 and 2), researchers figure out whether a new treatment is safe, what its side effects are, and the best dose of the new treatment. They also make sure that the treatment has some benefit, such as slowing tumor growth. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid
This video explains the three main phases of clinical trials.
Phase I trials look at how safe a treatment is and try to determine the best dose. Phase I trials may also test an already approved drug or therapy to try to improve its effectiveness or see if it can be used in a different way.
phase I trial tries to find out:
- To decide how the new treatment should be given (by mouth, in a vein, etc.)
- The safest dosage and the highest dose a person can tolerate
- To see how the new treatment affects the human body and fights cancer
- What side effects people taking the drug or treatment experience
Number of people taking part: 15–30
Phase II trials test the effectiveness of the drug based on the dose which was determined safe in a phase I. Phase II trials may also compare different schedules of giving the treatment.
- To determine if the new treatment has an effect on a certain cancer
- To see how the new treatment affects the body and fights cancer
- Continue to evaluate how safe the drug is
Number of people taking part: Less than 100
A phase III trial provides a detailed evaluation of a promising new treatment identified during a phase II trial. It compares the new treatment to the best current standard of cancer treatment. Researchers may test a drug alone or in combination with another drug or form of treatment.
- To compare the new treatment (or new use of a treatment) with the current standard treatment
- Compare side effects of the new treatment and the standard treatment
Number of people taking part: From 100 to several thousand
Some researchers design trials that combine two phases (phase 1/2 or phase 2/3 trials) in a single protocol. In this combined design, there is a seamless transition between trial phases, which may allow research questions to be answered more quickly or with fewer patients.
Phase IV trials gather more information about the possible risks and benefits of a drug that didn’t show up in earlier testing. Researchers look into risks and benefits that could be associated with long-term effects after a drug or treatment has been approved for clinical use.
QUESTIONS TO ASK ABOUT CLINICAL TRIALS
- Are any clinical trials available that I could take part in?
- What is the study purpose?
- What tests and treatments are part of the study?
- What does the treatment do?
- Has the study treatment been tested before? For what types of cancer?
- Will I know which treatment I receive?
- What is likely to happen to me with, or without, this new treatment?
- What are my other options? What are their benefits and risks?
- What does taking part in the study mean to my daily life?
- Can I expect side effects during the study? Can they be prevented or treated?
- Does the study involve a hospital stay? If so, how often and for how long?
- Will taking part in the study increase my chance of recovery?
- Does the study include follow-up care?
Last updated May 26, 2020
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Last Updated March 24, 2020
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