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July 23, 2019 - 1:53pm | 85°F

Research & Clinical Trials

Clinical Research Office

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Cancer Treatment Trials

Participation in a clinical trial is an important personal decision. The FAQ's provide information about clinical trials.

What is a Clinical Trial?

Clinical trials are research studies for newly developed treatments or investigational drugs that may reduce tumor size and eliminate symptoms better than treatments currently available. Each study answers scientific questions and tries to find a better way to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical trials have the opportunity to contribute to knowledge about the cancer, as well as progress in the treatment and prevention of cancer. People also receive up-to-date care from doctors who are cancer experts. The terms trial, protocol, and study are used interchangeably.

Why Participate in a Clinical Trial?

Participants in clinical trials play a more active role in their own health care and gain access to new research treatments before they are widely available. Participants help others by contributing to cancer research and possibly help find better treatments. Patients who participate in clinical trials are the first to receive the newest cancer treatments, as well as the best quality of care.

Who Can Participate in a Clinical Trial?

All clinical trials have strict guidelines regarding who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and factors that disallow someone from participating are called "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study.

Treatment trials seek patients with specific cancers to participate in the clinical trial, while prevention trials need healthy participants or people with a high risk for developing cancer. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. Ask your doctor if you are eligible for any clinical trials.

If you are eligible for a clinical trial, a doctor involved with the clinical trial or another member of the clinical trials team will carefully explain the details of the clinical trial to you and answer any questions you may have. You will be given a written copy of information about the trial, called a consent form. It is often helpful to talk to family members and friends before joining a trial.

No one is ever required to participate in a clinical trial. Participation in a clinical trial is completely voluntary, and a trial participant may decide to stop participating in a clinical trial without it affecting their relationship with their doctor, other medical staff, or their medical care.

Are There Alternatives to the Clinical Trial?

Usually standard treatments exist that people can choose to receive instead.

What Are the Different Types of Clinical Trials?

Treatment trials may test a new cancer drug or new combinations of drugs, new surgery techniques or radiation therapy, or new treatment methods such as gene therapy.

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer, to prevent cancer from returning, or to prevent a new cancer from occurring in people who already have had cancer. New methods of testing for cancer may be studied to determine better ways of detecting cancer at the earliest stages when it is most treatable.

Cancer control trials test new medicines, supplements, or other techniques to treat or prevent cancer symptoms and the side effects of cancer treatments.

What Are the Phases of Clinical Trials?

Clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to answer questions about a drug’s effectiveness and protects the patient. Clinical trials are usually classified into one of three phases:

Phase I trials: These first studies evaluate how a new drug should be given (by mouth, injected into the blood,, or injected into the muscle), how often, and what dosage is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical or radiation therapy procedure in comparison to the current standard treatment. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and are conducted at many doctors' offices, clinics, and cancer centers nationwide.

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