About Clinical Trials

What Is a Clinical Trial?

Clinical trials are key to improving current practices. In cancer research, clinical trials are conducted to improve cancer screening, prevention and detection, treatments, and patient quality of life. Most of the trials that are available through the Lombardi Comprehensive Cancer Center are designed to improve survival, improve cure rates, and/or reduce symptoms of disease or toxicities of treatments.

The ultimate goal of clinical trials is to identify new treatments that might be more effective, or less toxic than the standard treatments.

Click here to search the clinical trials open at Lombardi.

A good clinical trial means good clinical care.

Prior to initiating a clinical trial, the trial proposal is reviewed by several Georgetown University Medical Center committees to determine the scientific worth of the study, as well as its safety, and the ethics of its conduct. The final committee is the Institutional Review Board (IRB) of the hospital. Often, they are also reviewed by other groups, such as the National Cancer Institute (NCI) or the Food and Drug Administration (FDA).

Committee members include physicians, nurses, and people from the community who do not have medical training. The Committee evaluates not only the aspects of treatment, but specifically looks at ethical issues and potential risks and benefits to patients who will take part in the trial in question. Thus, when a trial is "open" and available to you, it has already passed multiple checkpoints. In most clinical trials available at Lombardi, people with cancer will be given therapies that might prove to be better than standard treatments. The treatment outlined in a clinical trial is generally considered to be at least as good as standard therapy, but might be better.

Before enrolling in a clinical trial, the pros and cons of participating will be explained to you in detail. A clinical trial might involve the addition or substitution of a specific drug, a change in a dose of a drug or a new way of administering the drug. Some trials compare two or more treatments, while others compare a new treatment modality with what is already considered standard therapy.

If enrolled in a trial, you will be followed very closely to monitor potential side effects. There are many safeguards in place, and if it is thought that a drug might be too toxic, a trial can be closed earlier than anticipated ("early closure"). Clinical trials are usually offered in large universities and cancer centers. In addition, a few private practices can offer you an opportunity to participate in large national trials.

What Types of Clinical Trials are Available?

Some of the available clinical trials are conducted by Lombardi alone, while other trials are conducted through large groups that involve many cancer centers throughout the United States. Lombardi is a member of several federally funded cooperative groups that conduct clinical trials, including CALGB (Cancer and Leukemia Group B) and NSABP (National Surgical Adjuvant Breast and Bowel Project).

There are different types, called Phases, of clinical trials. The phase of the trial depends on the type of drug, and how new it is.

Phase I:	This is a first phase when a new drug is tested in humans. The purpose of a Phase I trial is to determine the safety and a dose of a drug. A Phase I trial usually includes only a small number of patients, mostly those with an advanced cancer. More information about Lombardi's Phase I trials can be found on the Developmental Therapeutics Clinic page.
Phase II:	After the drug has been tested in a small group of patients, its safety established, and the proper dosage determined, a Phase II trial is initiated. In this phase, a larger number of patients will be included, and the effectiveness and side effect of the drug will be evaluated in a specific disease, such as breast cancer.
Phase III:	After a Phase II trial has shown a specific treatment is active against a specific type of cancer, a Phase III trial is initiated. In this phase, the new treatment, often in association with already established effective treatment, is compared to standard treatment alone. In this phase, a large number of patients is included and the effectiveness of the new drug or approach, and its side effects, are evaluated and compared to those of standard treatment. By definition, no one knows whether the investigational treatment will be the same, better, or worse than standard treatment. Thus, no one, including your doctor, could choose one "arm" over another as "best treatment." For every Phase III trial, it is equally likely that each patient may do as well, better, or worse than all other patients.

Who can participate in Clinical Trials?

Many clinical trials are available at the Lombardi Comprehensive Cancer Center for patients with different types and stages of cancer. All the patients who are interested in participating in a clinical trial are screened carefully. To take part in the study, you must have very specific medical conditions. You must also meet specific standards to qualify for treatment in the protocol.

These standards, referred to as eligibility criteria, are for your own well being. They will also ensure that the results of this study will be useful when choosing treatments for other patients with the same diseases. It is important that no exceptions be made to these eligibility criteria. We cannot and do not guarantee you will benefit personally if you take part in a study, but we also guarantee that we will fully explain your options and work closely with you so that you pick what you think is right for you. We also guarantee the best available care at the Lombardi Comprehensive Cancer Center regardless of how you are treated.

For more information on cancer clinical trials, contact the Lombardi CancerLine.

To search for open clinical trials at Lombardi, go to our Clinical Protocols page.