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Mesothelioma
Treatment
Clinical
Trials
Studies
of promising new or experimental
treatments in patients are known as
clinical trials. During a course of
treatment for lung cancer, the doctor may
suggest that a patient take part in a
clinical trial of a new treatment. A
clinical trial is only done when there is
some reason to believe that the treatment
being studied may be of value to the
patient. Treatments used in clinical
trials are often found to have real
benefits.
There
are three phases of clinical trials in
which a treatment is studied before the
treatment is eligible for approval by the
FDA (Food and Drug Administration).
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. Physicians
watch patients carefully for any harmful
side effects. The research treatment has
been well tested in laboratory and animal
studies, but the side effects in patients
are not completely predictable.
Phase
II trials determine the effectiveness of a
research treatment after safety has been
evaluated in a Phase I trial. Patients are
closely observed for an anticancer effect
by careful measurement of cancer sites
present at the beginning of the trial. In
addition to monitoring patients for
response, any side effects are carefully
recorded and assessed.
Phase
III trials require entry of large numbers
of patients; some trials enroll thousands
of patients. One of the groups may receive
standard (the most accepted) treatment, so
the new treatments can be directly
compared. The group that receives the
standard treatment is called the "control
group. " For example, one group of
patients (the control group) may receive
the standard chemotherapy for a certain
type of cancer, while another patient
group may receive another type of
chemotherapy that may or may not contain
an investigational drug to see if this
improves survival. All patients in Phase
III trials are monitored closely for side
effects, and treatment is discontinued if
the side effects are too severe.
Researchers
conduct studies of new treatments to
answer the following questions:
- Is
the treatment likely to be
helpful?
- Does
this new type of treatment work?
- Does
it work better than other treatments
already available?
- What
side effects does the treatment
cause?
- Do
the benefits outweigh the risks,
including side effects?
- In
which patients is the treatment most
likely to be helpful?
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 discover. While most side
effects will 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 that a
clinical trial may be beneficial in your
case.
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:
- What
is the purpose of the study?
- What
kinds of tests and treatments does the
study involve?
- What
does this treatment do?
- What
is likely to happen to me with, or
without, this new research
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?
If
you have any questions regarding treatment
options or your legal rights, please
contact
us.
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