What is a clinical trial?

Cancer clinical trials are research studies that evaluate a new treatment. The goal of these studies is to find better ways to diagnose, treat, or prevent cancer so that people can live better and longer. Many clinical trials use medications that have already shown hope of working better than the standard treatment. Often, studies involve adding a new medicine to a current treatment, or testing a new treatment against a current treatment to see which works better. People who take part in a clinical trial may be the first to receive a new treatment. Clinical trial patients are closely monitored by doctors, research staff, and other professionals.

How do I find out if I qualify for a clinical trial?

A clinical trial is not the right choice for all patients. The first priority in any clinical trial is the safety of the patient. As a result, each study has strict rules that doctors are required to follow when deciding if a patient can join the trial. These rules are called “eligibility criteria”. The reason for these criteria is to protect patients from receiving a treatment that may harm them. The following are often included:

• Cancer type and stage
• Other treatments you may have had for your cancer
• Amount of time since last treatment
• Age and gender
• Results of medical tests (e.g. labs, x-rays, CT or MRI scans)
• Other health problems
• Medicines you are taking

Who do I talk to about whether a clinical trial is a good choice for me?

Talk to your doctor. He or she is the most familiar with your health and can tell you if there are any clinical trials available for someone with your type and stage of cancer. If the doctor offers a clinical trial, you will given all the information for the trial through a process called informed consent. All of the details of the trial will be reviewed in detail with you. There will be an informed consent document that will tell you:

• The purpose of the study
• Who is eligible
• What is known about the treatment and what is experimental
• Known risks and benefits of the treatment
• Other treatment options
• Required tests, doctor visits and treatment schedules
• Who pays for the costs of the clinical trial
• How your privacy will be protected
• Who to contact if you have questions

Before you sign up for a clinical trial, make sure you understand exactly what treatment is being offered and how it differs from the standard treatment available for your cancer. Ask any questions you may have about side effects, study schedules, costs, or anything else. Our goal is for you to have the information you need to make an informed decision.

How do I find out about the costs involved?

The informed consent will give you information on any medicines or tests that are paid for by the study. Often the study will cover the cost of any new drugs being studied, however you may or your insurance may need to pay for other costs associated with study participation, including drugs that are already approved for use for your type of cancer. You are encouraged to check with your insurance provider for information about coverage for research procedures, and standard of care procedures. It may be helpful to talk with the research team about insurance coverage and questions you may have.

For information about costs associated with clinical trials, go to Clinical Trials and Insurance Coverage from the National Cancer Institute at: http://www.cancer.gov/clinicaltrials/learning/insurance-coverage

For information regarding Medicare coverage of clinical trials, go to http://www.cancer.gov/clinicaltrials/conducting/medicare

The UW Cancer Center-Riverview receives research support through our affiliation with the University of Wisconsin, allowing our site to offer research studies for a variety of cancer diagnosis. This allows our patients the opportunity to take part in a clinical trial without having to travel to receive care.

Clinical trials are available through several groups, including:

-Eastern Cooperative Oncology Group (ECOG), offering national clinical trials in all types of cancer through National Cancer Institute funding.

-Radiation Therapy Oncology Group (RTOG), devoted solely to research in radiation therapy for all types of cancer with funding through National Cancer Institute.

-Wisconsin Oncology Network (WON), regional network established to allow community health centers to enroll patients in select cancer clinical trials that are open the UW Paul P. Carbone Cancer Center.

-Cancer Trials Support Unit, a research group sponsored by the NCI to provide greater access to cancer trials, allowing access to studies from other national clinical trial groups

There are typically have between 15 to 20 clinical trials available for patient participation. For more information about available clinical trials, you can contact the research nurse at 715-422-7718, or toll-free at 1-800-732-1956, extension 7718.

If you have questions about additional research studies available at the University of Wisconsin, you can contact:

UWCCC Cancer Connect, 1-800-622-8922 or 608-2620-5223, uwccc@uwccc.wisc.edu

Where can I get more information?

For more information regarding clinical trail participation, you can access the following internet resources:

Taking Part in Clinical Trials: What Patients Need to Know from the NCI, at http://www.cancer.gov/clinicaltrials/Taking-Part-in-Cancer-Treatment-Research-Studies

Learn About Clinical Trials from the NCI, at http://www.cancer.gov/clinicaltrials/learning