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Clinical Research

  • What is a clinical trial?

Clinical Trials may best be defined as studies or protocols which address a specific kind of disease (in this case, cancer, in its various forms) and often look at what is considered to be the standard treatment and compare it to a new treatment, usually with a different "twist" on the way drugs or therapy is given. The goal of performing trials in these methodologies, including chemotherapy, radiation therapy and surgery is that, used in new ways, they will improve a patient's quality of life. Prevention studies are also available for patients at high risk of developing cancer.

Oncology Clinical Trials Program

Since it's inception in 1989, the Oncology Clinical Trials Program has grown to include various National Clinical Trials groups such as Cancer and Leukemia Group B (CALGB) and Radiation Therapy Oncology Group (RTOG) as well as various studies from pharmaceutical companies and various chemoprevention studies for breast, colon and lung cancers.

At the present time, the Program has over 275 patients enrolled, with new protocols (clinical trials) opening to enrollment monthly. Physicians from Medical and Radiation Oncology, as well as Surgery, play a crucial role in the enrollment of these patients, while clinical research nurses and data management staff are intimately involved in the enrollment, treatment documentation and follow-up of all the patients.

Each protocol contains a very specific description on the type of treatment, dose and potential toxicities associated with the overall cancer therapy. Each patient who enrolls in a clinical trial must sign an Informed Consent (a written synopsis about the protocol with a descriptive narrative about the treatment including potential benefits and risks and what role the physician and hospital play in the patient's overall treatment). Once a patient is enrolled in a study, he/she may choose for any reason to discontinue treatment and be assured that standard therapy will be available, without bias, by the physician.

Patients are followed for their lifetime regardless of whether they finish treatment on protocol or go onto some other treatment. It's the objective of this program to ensure that information is accurate, up-to-date and follows protocol guidelines. The standards, which must meet federal and local regulations, are high, as are the expectations of the staff involved in the Clinical Trials process.

Examples of a Clinical Trial

A patient may receive the same chemotherapy as in the standard treatment, but the dose may be slightly more or less than standard, or it may be given with Radiation Therapy.

Two types of chemotherapy may be compared, or different doses of the same drug may be studied to
see which works better for the patient, i.e. having fewer toxicities, better quality of life or longer
disease-free interval.