111 Park Hill Drive, Suite B
Fredericksburg, Virginia 22401
Current topics in Oncology
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What are the real issues behind the uproar surrounding mammogram screening recommendations?
. Adjuvant Therapy for Colon Cancer
New developments in measuring and reducing the risk of colon cancer recurrence
About Clinical Trials
Advancing High Quality Care
Fredericksburg Oncology is affiliated with the National Cancer Institute's Community Clinical Oncology Program (CCOP), and is now able to offer clinical trials to patients in Fredericksburg. These trials are sponsored by national research groups, including the NSABP (National Surgical Adjuvant Breast and Bowel Project), ECOG (Eastern Cooperative Oncology Group), CALGB ( Cancer and Leukemia Group B), and the NCCGT (North-Central Cancer Treatment Group). Fredericksburg Oncology does not participate in trials run by pharmaceutical companies.
What are clinical trials?
A clinical trial is a medical research study conducted by doctors to test new methods of prevention, screening, diagnosis, or treatment of cancer. A clinical trial might also be called a clinical study, or a research protocol, or medical research. Carefully conducted clinical trials are the safest and surest way to develop improved treatments against cancer.
A randomized clinical trial is a study in which the participants are assigned by chance to either the standard treatment group (control group) or the investigational treatment group. In clinical cancer trials the control group receives the standard treatment currently available. Sometimes during the course of a trial one arm is found to be clearly superior. If this happens the study is closed early, and all patients are offered the best treatment.
Why take part in a clinical trial?
Clinical trials offer high-quality cancer care. By participating in a clinical trial patients often play a more active role in their healthcare, and may be helping others who have the same condition by contributing to medical research. By participating in a trial patients may have access to treatments that are not otherwise available, and increase the total number of treatment options available to them. Because of the careful monitoring of the treatment, and of the potential side effects, patients on trial receive very close attention from the health care team. There are, of course, potential risks.
Each person with cancer should have the opportunity to consider participation in a clinical trial. It is a personal choice to participate or not. A decision should only be made after a careful review of the trial and of the consent form with the physician.
What is a protocol?
The protocol is a map, or blueprint, that outlines in detail the tests, treatments, and doses of medicines that will be used. It ensures that all patients are treated identically and all results are measured the same way, so that meaningful comparison can be made when the trial is completed.
What types of cancer trials are available?
There are different types of clinical trials, designed to answer different questions.
A Phase I clinical trial is designed to determine if a new treatment is well tolerated, and what the appropriate dose of a new medication should be.
A Phase II clinical trial is designed to measure the effectiveness of a particular treatment against a particular disease. These studies typically involve 100 to 300 people.
A Phase III trial compares the new treatment that with a standard therapy for a particular type of cancer. Phase III studies typically involve 1000 to 3000 patients enrolled at oncology practices across the country. The majority of trials available at Fredericksburg Oncology are Phase III clinical trials.
How am I protected if I am involved in a clinical trial?
Before a clinical trial starts, a review board evaluates the proposed trial to be sure it is scientifically sound and will be conducted in an appropriate and ethical manner. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board. An IRB is an independent committee of physicians, statisticians, and community advocates that ensures a clinical trial is ethical and that the rights of study participants are protected. Patients are under absolutely no obligation to enroll in a clinical trial, and are free to leave a clinical trialat any time.
Fredericksburg Oncology receives no compensation from any pharmaceutical company or research organization for recruiting or enrolling patients in any clinical trial.
Some common misconceptions:
|Myth:||Clinical trials are risky.|
|FACT:||Trials are very closely monitored by the doctors and nurses, and there is continuing oversight by the Institutional Review Board assigned to each trial.|
|Myth:||Clinical trials are highly experimental and patients are treated like "guinea pigs".|
|FACT:||Clinical trials generally incorporate the best available medicine and then add to it or adjust it to see if enhancements can be made to improve the quality of the treatment and the quality of life of patients receiving that treatment.|
|Myth:||Sugar pills or placebos are often used in clinical trials rather than actual medicine.|
|FACT:||Clinical trials offer patients the best treatment (the standard of care) or the opportunity to receive a new treatment, which is hoped to be proven better than the standard. Placebos are rarely used in treatment trials. It would be unethical to give someone an inactive medication if it would deny him or her the chance to receive treatment that has already been shown to work. The very least the patient should expect in any clinical trial is to be offered the standard of care already in use.|
|MYTH:||Health-insurance doesn't cover treatment costs for clinical trials.|
|FACT:||The majority of insurance companies cover treatment on cancer clinical trials. Since June 2000, Medicare has covered the cost of treatment trials.|