If you are interested in pursuing clinical trials, please schedule a consult with your oncologist.
About Clinical Trials
Clinical trials, which exist for almost every type of cancer, are experiments to determine the value of specific cancer treatments. Trials may involve chemotherapy, radiation therapy, surgery, new experimental modalities, or any combination of these treatments. Such trials include national, international, and institutional research trials. Each one must be approved by an Institutional Review Board (IRB), which is composed of physicians, researchers, and non-medical members. The IRB decides whether a proposed study is reasonable, appropriately designed, and safe for patients. Anyone considering joining a clinical research trial must be fully informed about the trial details, including the benefits and risks, and must sign an informed consent form.
The different types of clinical trials are divided into the following phases:
The purpose of Phase I clinical trials is to determine the appropriate dose of a drug. Phase I trials typically include patients who have advanced disease that is resistant to standard treatments. Drug dosage is typically increased as additional patients are added to the study to determine the maximum-tolerated dose.
The purpose of Phase II clinical trials is to measure the biologic response of a particular tumor to a specific treatment. Phase II trials typically include patients who have a tumor for which an effective therapy does not exist. Single agents and combination regimens may be evaluated in these trials. The goal of a combination regimen Phase II trial is to ensure that the treatment is feasible, safe, and promising before continuing to the next phase.
The purpose of Phase III clinical trials is to compare an experimental treatment to an accepted standard of care and evaluate endpoints such as survival and symptom control. Phase III trials are typically performed in multi-institutional settings that include physicians from the community. Clinical research trials are extremely important in expanding options for treatment of all cancers. The treatments that are available today exist because of the participation of other cancer patients in clinical research trials. Researchers are constantly trying to identify better treatments for cancer, including less toxic treatments or agents, which can protect the body's normal tissues and, therefore, minimize side effects of treatment. Clinical research trials are very rewarding for both the patient and the physician. The patient may benefit from new treatment options and help future cancer patients in their fight against this disease.