Bone Cancer
Detailed
Guide: Bone Cancer
Clinical Trials
The
purpose of clinical trials: Studies of promising new or
experimental treatments in patients are known as clinical
trials. A clinical trial is only done when there is some
reason to believe that the treatment being studied may be
valuable to the patient. Treatments used in clinical trials
are often found to have real benefits. Researchers conduct
studies of new treatments to answer the following questions:
* Is the treatment helpful?
* How does this new type of treatment work?
* Does it work better than other treatments already available?
* What side effects does the treatment cause?
* Are the side effects greater or less than the standard
treatment?
* Do the benefits outweigh the side effects?
* In which patients is the treatment most likely to be helpful?
Types
of clinical trials: There are 3 phases of clinical trials
in which a treatment is studied before it is eligible for
approval by the FDA (Food and Drug Administration).
Phase
I clinical trials: The purpose of a phase I study is to
find the best way to give a new treatment and how much of
it can be given safely. The cancer care team watches patients
carefully for any harmful side effects. The treatment has
been well tested in lab and animal studies, but the side
effects in patients are not completely known. Doctors conducting
the clinical trial start by giving very low doses of the
drug to the first patients 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 the cancer.
The cancer care team also looks for side effects.
Phase
III clinical trials: Phase III studies involve large numbers
of patient – 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 trial: Enrollment in any 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:
* Is there a clinical trial for which I would be eligible?
* What is the purpose of the study?
* What kinds of tests and treatments does the study involve?
* What does this treatment do? Has it been used before?
* Will I know which treatment I receive?
* What is likely to happen in my case with, or without,
this new treatment?
* What are my other choices and their advantages and disadvantages?
* How could the study affect my daily life?
* What side effects can I expect from the study? Can the
side effects be controlled?
* Will I have to be hospitalized? If so, how often and for
how long?
* Will the study cost me anything? Will any of the treatment
be free?
* If I am harmed as a result of the research, what treatment
would I be entitled to?
* What type of long-term follow-up care is part of the study?
* Has the treatment been used to treat other types of cancers?
The
American Cancer Society offers a clinical trials matching
service for patients, their family, and friends. You can
reach this service at 1-800-303-5691 or on our Web site
at http://clinicaltrials.cancer.org. Based on the information
you provide about your cancer type, stage, and previous
treatments, this service can compile a list of clinical
trials that match your medical needs. In finding a center
most convenient for you, the service can also take into
account where you live and whether you are willing to travel.
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The information on this page has been extracted from http://www.cancer.org/docroot/CRI/content/
CRI_2_4_4X_Clinical_Trials_2.asp?sitearea=.
