Abstract: . . .  and increasing the dose for later groups of patients until side effects appear. Although doctors are hoping to help patients, the main purpose of a phase I study is to test the safety of the drug. Phase II clinical trials: These studies are designed to see if the drug works. Patients are given the highest dose that doesn’t cause severe side effects (determined from the phase I study) and closely observed for an effect on file:///c|/temp/catalog/INDEX.HTM (16 of 28) [6/29/2006 11:24:16 AM] Page 17 PANCREATIC CANCER - All Sections the cancer . The cancer care team also looks for side effects. Phase III clinical trials: Phase III studies involve large numbers of patients—often several hundred. One group (the control group) receives the standard (most accepted) treatment. The other group receives the new treatment. All patients in phase III studies are closely watched. The study will be stopped if the side effects of the new treatment are too severe or if one group has had much better results . . .
. . .  clinical trial is completely up to you. Your doctors and nurses will explain the study to you in detail and will give you a form to read and sign indicating your desire to take part. This process is known as giving your informed consent. Even after signing the form and after the clinical trial begins, you are free to leave the study at any time, for any reason. Taking part in the study does not prevent you from getting other medical care you may need. To find out more about clinical trials, ask your cancer care team. Among the questions you should ask are: q Is there a clinical trial for which I would be eligible? q What is the purpose of the study? q What kinds of tests and treatments does the study involve? q What does this treatment do? Has it been used before? q Will I know which treatment I receive? q What is likely to happen in my case with, or without, this new treatment? q What are my other choices and their advantages and disadvantages? q How could the study affect my daily life? q . . .
. . .  patients—often several hundred. One group (the control group) receives the standard (most accepted) treatment. The other group receives the new treatment. All patients in phase III studies are closely watched. The study will be stopped if the side effects of the new treatment are too severe or if one group has had much better results than the others. If you are in a clinical trial, you will have a team of experts taking care of you and monitoring your progress very carefully. The study is especially designed to pay close attention to you. However, there are some risks. No one involved in the study knows in advance whether the treatment will work or exactly what side effects will occur. That is what the study is designed to find out. While most side effects disappear in time, some can be permanent or even life threatening. Keep in mind, though, that even standard treatments have side effects. Depending on many factors, you may decide to enroll in a clinical trial. Deciding to enter a clinical . . .
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