Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of clinical trials is to find better ways to treat cancer and help cancer patients. Clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy.
Clinical trials come at the end of a long and careful research process, which begins in the laboratory. If the treatment seems promising, then researchers may test it on animals. If those continue to seem promising, the treatment moves into a clinical trial phase, studied with people to see how effective and safe it is.
Why clinical trials are important
Clinical trials are important in two ways. First, clinical trials provide the latest in advanced thinking and technology to patients with cancer with the objective of improving clinical outcomes. Second, they contribute to the knowledge of and progress against cancer. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Many of today's most effective standard treatments are based on previous study results. Clinical trials may also answer important scientific questions and suggest future research directions.
Clinical trial phases
Cancer clinical trials include research at three different phases:
Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers look for the best way to give an experimental therapy. They also try to find out if and how the treatment can be given safely (e.g., best dose), and they watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include only a limited number of patients who would not be helped by other known treatments.
Phase II trials focus on learning whether the experimental therapy has an anticancer effect (e.g., Does it shrink a tumor? Improve blood test results?). As in Phase I, only a small number of people take part because of the risks and unknown variables involved.
Phase III trials compare the results of people taking the experimental therapy with the results of people taking standard treatment (e.g., Which group has better survival rates? Fewer side effects?). In most cases, studies move into Phase III testing only after a therapy shows promise in Phases I and II. Phase III trials may include hundreds of people around the country. Comparing similar groups of people taking different treatments for the same type of cancer is another way to make sure that study results are real and caused by the treatment, rather than by chance, or other factors. Comparing treatments with each other often shows clearly which one is more effective and/or has fewer side effects.
Search for a clinical trial
Browse clinical trials specific to radiation oncology treatments available at Johns Hopkins or search for an open clinical trial available at The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center