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Clinical Research
Clinical Research
Most advances in the diagnosis, treatment and care of patients with cancer have occurred because of research studies called "clinical trials" or "protocols." Clinical trials are designed to help health care professionals test new approaches to the diagnosis, treatment or prevention of cancer.
Improved diagnostic tests and new treatments have led to cures for patients with some cancers. Clinical trials that study the effect of cancer treatments such as surgery, radiation therapy, chemotherapy and biological therapy have helped health care professionals find better ways to treat cancer.
Cancer patients and people who are at high risk for developing cancer are often asked to participate in a clinical trial. Clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, or new combination's of treatment or new methods, such as gene therapy.
Patients are never denied a known, effective treatment. And researchers believe that the new treatment or drug may improve their health.
Patients and their families should gather as much information as needed in order to be able to make an informed decision about participating in a clinical trial.
As members of national cooperative groups such as National Surgical Adjuvant Breast and Bowel Project (NSABP), Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG) and the Cancer Trials Support Unit (CTSU), large cooperative groups that write the trials clinical trials, The RCC offers patients access to the same clinical trials available at large, well known academic cancer centers. In addition, through an affiliation with UPMC CancerCenter / University of Pittsburgh Cancer Institute (UPCI), The RCC is part of the UPMC network of clinical trial sites.
Various clinical trials involving use of Radiation Therapy require validation of the entire treatment process including treatment planning and delivery by a National Organization such as Radiological Physics Center (RPC) at the MD Anderson Cancer Center in Houston, Texas. The process involves simulating patient treatment planning and delivery for each specific clinical site using a specially designed phantom provided by RPC. The actual dose delivered to various parts of the phantom is measured by RPC and compared to the planned dose. This phantom study provides an accurate analysis of the quality of treatment patients will receive at The Regional Cancer Center and it is required for participation in all protocols.
Cancer clinical trials include research at three different phases. Each phase answers different questions about the new treatment. Phase I trials are not conducted at The RCC; the majority of trials open at The RCC are Phase III trials.
- Phase I trials are the first step in testing a new treatment in humans. These studies usually include only a limited number of patients who would not be helped by other known treatments.
- Phase II trials focus on learning whether the new treatment has an anticancer effect, such as shrinking a tumor or improving blood test results.
- Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment to compare variables such as survival rates and side effects. In most cases, studies move into Phase III testing only after a treatment shows promise in Phases I and II.
The Center’s certified regional tumor registry tracks treatment and outcomes of cancers for study by health care and research professionals. In this way, the Center and its patients are contributing to the ultimate fight against cancer.
What to expect from participation in clinical research at RCC
- New patients are screened for possible enrollment in clinical trials coordinated through our research department. Research nurses, working with treating physicians, identify opportunities and present options to patients for consideration.
- Clinical trial participation includes a thorough consent process; research nurses work closely with patients while they consider participation and also follow their progress personally during treatment.
- Participating in a trial may or may not improve a patient’s health but will help answer questions about what treatment is best.
Is there a clinical trial available that’s right for me at The RCC?
Currently clinical trials are available for the following cancer types: lung cancer, brain tumor, head and neck cancer, esophageal cancer, colon cancer and prostate cancer.
If not, is there somewhere else I can go?
There may be a clinical trial available elsewhere. Talk with your doctor, he can refer you to UPMC or another institution for trial participation. The National Cancer Institute and Trial Check are websites that can help refine your search for trials that may interest you.
Who qualifies for clinical trials?
Patients must meet strict eligibility requirements such as the histology of the cancer, stage of cancer and being free from other health problems to qualify. The research team and your doctor identify you as a potential candidate and will ensure you meet eligibility.
Who do I go to in order to find out more about clinical trials outside The RCC?
You can speak with a research nurse or your doctor. They can get you started on the right track to look for a trial that may interest you.
The RCC Institutional Review Board (IRB)
Any organization participating in clinical trials is required to have an IRB designed to protect patients who take part in clinical studies. IRBs review and must approve the protocols for all clinical trials funded by the Federal Government. IRBs check to see that the study is well-designed, does not involve undue risks, and includes safeguards for patients. Clinical trials open at The RCC are reviewed by IRBs from Hamot Medical Center, Saint Vincent Health Center and UPMC CancerCenter that are comprised of scientists, doctors, clinicians, clergy and consumers.
Patient rights and safety are priorities of all clinical research activities. All ethical principles and guidelines for the protection of human subjects of research are strictly followed.
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