Cancer Clinical Trials

At any one time, there are numerous cancer clinical trials going on that seek to improve the care and outcome for cancer patients worldwide. Some of these trials involve only our patients; other trials include people from across the U.S. or from other countries.

Northern Indiana Cancer Research Consortium

The Northern Indiana Cancer Research Consortium (NICRC) is a group of medical institutions joined together to support cancer research in the Northern Indiana region. These member institutions are Elkhart General Hospital, LaPorte Hospital, Memorial Hospital of South Bend, and St. Joseph Regional Medical Center. Lakeland Hospital in St. Joseph, Michigan has also joined the NICRC.

Community Clinical Oncology Program

The Community Clinical Oncology Program (CCOP) is a major long-term effort in cancer control to reduce cancer morbidity and mortality. The CCOP is funded through a grant from the National Cancer Institute (NCI) through the National Institute of Health. The Northern Indiana CCOP is the first in the state of Indiana. Currently there are 20 regional medical investigators, a psychosocial investigator, nurses and multi-specialists that are participating in clinical research through the NICRC and CCOP. The advantages of a CCOP are its ability to offer state of the art cancer treatment, access to investigational drugs through the NCI, access to clinical trials, and patient assurance of the best possible cancer care.

Patients who are enrolled in clinical trials are more likely to receive overall better treatment for several reasons. Treatment regimens must be strictly followed, monitoring is rigid and consistent, and follow-up is mandatory. Patients entering a clinical trial are carefully educated about the treatment and must sign a patient informed consent approved by the CCOP Institutional Review Board.

The NICRC and CCOP have about 120 clinical trials for most cancer disease sites and stages. Also there are several Prevention Trials open for breast cancer, (STAR Trial), prostate cancer (SELECT Trial) and a smoking cessation trial for lung cancer prevention. A Proteomics Trial has been opened to study specific proteins in blood of patients with cancer and also for people without a current diagnosis of cancer.

What is a Clinical Trial?

In cancer research, a clinical trial is a study conducted with cancer patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help cancer patients.

The search for good cancer treatments begins with basic research in laboratory and animal studies. The best results of that research are tried in patient studies, hopefully leading to findings that may help many people.

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. But this early research cannot predict exactly how a new treatment will work with patients.

With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work.

Standard treatments, the ones now being used, are often the base for building new, hopefully better treatments. Many new treatments are designed on the basis of what has worked in the past, in efforts to improve on this.

Only patients who wish to, take part in a clinical trial. You may be interested in or asked to enter a trial. Learn as much as you can about the trial, before you make up your mind.

The Importance of Clinical Trials

Clinical trials are important because they help bring about new treatments and sometimes even a cure. Long before a clinical trial begins, new methods and treatment undergo extensive research in the laboratory. Only medications that show promise are brought to clinical trial. A trial tests a new type of treatment scientists hope will prove better or more effective than standard treatments currently being used. You should discuss the possibility of participating in a clinical trial with your physician.

Understanding What the Trial Is

Before a patient is enrolled in a trial he or she must understand all of its potential risks and benefits. Cancer patient may enroll in trials investigating new types of chemotherapy, surgery, radiation therapy or other types of treatment under development. Like any cancer treatment, treatment given during a clinical trial can have side effects and risks. Patients are asked to sign informed consent forms before receiving their first treatment and are monitored carefully during the length of the trial. Patients may see the doctor more often and have more tests than they would if they received an already accepted form of treatment.

Trials are often specific to one type of cancer, such as lung cancer or prostate cancer. Information learned can sometimes be applied to other types of cancer, broadening the use of the results.

Phases of Clinical Trials

Cancer clinical trials are divided into three phases:

• Phase I trials usually involve only a small number of patients, and attempt to determine the best dosage of the drug being used, and if it is safe.
• Phase II trials then investigate whether the drug is beneficial to patients with this specific disease, such as lung cancer or ovarian cancer, or class of disease, such as sarcomas. Generally more patients are enrolled in these trials. Combinations of drugs may also be evaluated in Phase II.
• Phase III. If the therapeutic agents appear promising, Phase III trials then compare the results from the experimental treatment to standard therapies already in use. Researchers may ask whether the new drug is better than the current treatment and how side effects compare.

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For more information

For further information on Clinical Research, contact the Oncology Research Nurse at (574) 296-6536.