NCCN Guidelines for Patients® | Ovarian Cancer - page 51

51
Part 5: Treatment with cancer drugs
NCCN Guidelines for Patients
®
: Ovarian cancer
Version 1.2013
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Clinical trials
A clinical trial is a type of research that studies a test or treatment. Tests and
treatments aren’t offered to all patients as soon as they’re made. They must be
tested in clinical trials first. When tests and treatments are found to be safe and
helpful, they may become tomorrow’s standard of care. However, there is no way
to know this before the trial is done.
Clinical trials are done in a series of steps, called phases. This is to fully study
how safe and helpful a test or treatment is for patients. The four phases of clinical
trials are described next using the example of a new drug treatment:
Phase I
trials aim to find the best dose and way to give a new drug with the
fewest side effects. If a drug is found to be safe, it will be studied in a phase II
trial.
Phase II
trials assess if a drug works for a specific type of cancer. They are done
in larger groups of patients with the same type of cancer.
Phase III
trials compare a new drug to the standard treatment or a fake treatment
(placebo). These are randomized, meaning patients are put in a treatment group
by chance.
Phase IV
trials test new drugs approved by the FDA (
F
ood and
D
rug
A
dministration) to learn more about side effects and safety. They involve many
patients with different types of cancer.
There may be an open clinical trial you can join. To join a clinical trial, you must
meet the conditions of the study. Patients in a clinical trial often have a similar
cancer type and general health. This helps ensure that any response is because
of the treatment and not because of differences between patients. You also must
review and sign a paper called an informed consent form to join a clinical trial.
This form describes the study in detail, including the risks and benefits.
Definitions:
Chemotherapy cycle:
Days of treatment followed
by days of rest
FDA:
A federal government
agency that regulates
drugs and food
Observation:
A period of
testing after treatment to
check that treatment worked
Primary chemotherapy:
The first or main
chemotherapy drug or
drugs given to treat cancer
Side effect:
An unplanned
physical or emotional
response to treatment
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