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GYN Oncology Clinical Trials

The Gynecologic Oncology staff at Ellis Fischel Cancer Center is committed to improving the care and treatment for patients who are diagnosed with a gynecologic cancer. An important way we are doing this is to have the most up-to-date treatments available to the patients we serve. One way to receive the most cutting edge treatment is to participate in clinical trials.

The Gynecologic Oncology staff participates in clinical trials through the Gynecologic Oncology Group (GOG). These are large nation-wide studies funded by the National Cancer Institute (NCI). We also participate in national and international trials funded by pharmaceutical companies. We have exciting clinical trials available for many sites of female cancer-including novel approaches in the treatment of ovarian cancer, such as tumor vaccines and tumor antibodies.

What is a clinical trial?

Clinical trials are studies done with people that test promising treatment and prevention methods, and answer key scientific questions. The information gained from these studies leads to future advances in care. Standard treatments, the ones now being used, are often the starting point for building new, hopefully better treatments. Many new treatments are developed on the basis of what has worked in the past, in an effort to improve on these results. When new methods of treatment are proven to be better, and the doctors begin using them, the purpose of clinical trials is fulfilled-patients obtain improved results. Clinical trials are important because they evaluate the effectiveness of new treatments, which can increase survival rates, lessen treatment side effects, and improve quality of life.

What are the stages of the research process?

Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed, and as much as possible, shows how to use them safely and effectively. With any new treatment there may be risks as well as possible benefits. There may also be risks that are not yet known. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work.

Why would a patient be interested in a Clinical Trial?

Patients take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. They may hope for a cure of disease, a longer time to live, a way to feel better. Often they want to contribute to a research effort that may help others. Although there is always a chance that a new treatment will be disappointing, the researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments.

The patients in a clinical trial are among the first to receive new research treatments before they are widely available. Clinical trials sponsored by national organizations (NCI, GOG, etc…) are written by experts in their fields of study, making it possible for patients to benefit from famous researchers and clinicians in top treatment centers across the nation and the world. How a treatment will work for a patient in a trial can't be known ahead of time. Even standard treatments, although helpful in many patients, do not carry sure benefits for everyone. All patients in clinical trials are carefully monitored during a trial and followed up afterwards.

As a patient, it can be hard to decide about your treatment. There are a number of things to consider. Cancer is a life-threatening disease that causes symptoms of its own, not related to treatment. In each case, the unavoidable risks of the cancer itself, and your health, should be considered against the possible risks and benefits of a new research treatment. Standard treatments, as well as treatments in clinical trials, can also cause side effects and risks.

Are you eligible for a Clinical Trial?

Every clinical trial is set up to answer a set of research questions. If you fit the guidelines for a trial, you may be eligible to take part. Each study enrolls patients with certain types and stages of cancer. A study that involves two or more treatments can give reliable answers only if all the patient cases are similar, so they can be compared with one another. The strict requirements for a clinical trial also protect patients, as well as researchers. Safe guards are built in to make sure the patient is healthy enough to make treatment reasonably safe, so that the right patient with the right disease and health status receives the right treatment.

What is informed consent?

Informed consent is required in studies that are federally regulated or funded, as well as by state laws. Informed consent means that as a patient, you are given information so you can understand what is involved in a trial, this includes the potential benefits and risks, and the nature of the treatment. You are given an informed consent form to read and consider carefully. Ask any questions you may have. Then, if you agree to take part, you can sign the form-of course, you can also refuse.

If you enter a trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial. Signing a consent form does not bind you to the study. You can still choose to leave the study at any time.

What protection do you have as a Patient in a Clinical Trial?

The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated or federally funded (at least in part), with built-in safeguards to protect patients. These safeguards include regular review of the protocol and the progress of each study by researchers at other places.

Federally regulated clinical trials must first be approved by an Institutional Review Board (IRB) located at the institution where the study is to take place. IRBs, designed to protect patients, are made up of scientists, doctors, clergy, and other people from the community. An IRB reviews a study to see that it is well designed with safeguards and to assure that the risks are reasonable in relation to the potential benefits.