Radiation Oncology Clinical Trials

What are Clinical Trials?

Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of this research 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.

A clinical trial is one of the final stages of a long and careful cancer research process. The search for new treatments begins in the laboratory, where scientists first develop and test new ideas. If an approach seems promising, the next step may be testing a treatment in animals to see how it affects cancer in a living being and whether it has harmful effects. Of course, treatments that work well in the lab or in animals do not always work well in people. Studies are done with cancer patients to find out whether promising treatments are safe and effective.

Cancer clinical trials include research at three different phases.

Each phase answers different questions about the new treatment.

• 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 a new treatment (e.g., by mouth, IV drip, or injection? how many times a day?). 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 new treatment 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 unknowns involved.

• Phase III trials compare the results of people taking the new treatment with 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 treatment 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 or has fewer side effects.

Trial Status

Open trials: These are trails that are currently open to accrual.

Pending trials: Trials that have been developed and are waiting final approval before patient recruitment can occur

Closed: Trials that are no longer adding patients to the studies. There may be some studies that still have patients enrolled and are in folllow up status.

Why are Clinical Trials important?

Clinical trials are important in two ways.

First, cancer affects us all, whether we have it, care about someone who does, or worry about getting it in the future. Clinical trials contribute to knowledge 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. Examples include treatments for breast, colon, rectal, and childhood cancers. Clinical trials may also answer important scientific questions and suggest future research directions. Because of progress made through clinical trials, many people treated for cancer are now living longer.

Second, the patients who take part may be helped personally by the treatment(s) they receive. They get up-to-date care from cancer experts, and they receive either a new treatment being tested or the best available standard treatment for their cancer. Of course, there is no guarantee that a new treatment being tested or a standard treatment will produce good results. New treatments also may have unknown risks. But if a new treatment proves effective or more effective than standard treatment, study patients who receive it may be among the first to benefit. Some patients receive only standard treatment and benefit from it.

In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial.

For more Clinical Trials Information, please call 410-955-8804.