NCCN Guidelines for Patients
Pancreatic Cancer, Version 1.2014
Overview of cancer treatments Clinical trials
A clinical trial is a type of research that studies a test
or treatment. Because of clinical trials, the tests and
treatments in this book are now widely used to help
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 an important treatment option for
people with pancreatic cancer. Until recently, not
many clinical trials had been done to find tests and
treatments for pancreatic cancer. Thus, doctors are
still studying what tests and treatments work best.
NCCN experts recommend that you talk with your
treatment team about joining a clinical trial.
Clinical trials can study many things, such as:
• New drugs not yet approved by the FDA
• New uses of drugs already approved by the
• New ways to give drugs, such as in pill form,
• New tests to find and track disease, and
• Drugs or procedures that relieve symptoms.
New clinical trials for pancreatic cancer aim to study:
• Better ways to identify who is at risk for
• Early signs of pancreatic cancer so it can be
• Better ways to image pancreatic cancers,
• New systemic therapy drugs to treat
• New methods of giving radiation therapy,
• Which treatments work best to shrink a tumor
for surgery, and
• Which treatments work best to kill cancer cells
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. These are randomized, meaning patients
are put in a treatment group by chance.
Phase IV trials
test new drugs approved by the
FDA to learn about short-term and long-term side
effects and safety. They involve many patients with
different types of cancer.
There may be an open clinical trial that 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