FAQs and Glossary
What is a
cancer clinical trial?
A cancer clinical trial is a research project that aims
to see whether an investigational drug or treatment is effective and
What are the
advantages of enrolling in a clinical trial?
Advantages to enrolling in a clinical trial may include:
(1.) The ability to get early access to a new medication or
treatment, often before they are more widely available; (2.) the
opportunity to choose a treatment approach that is aligned with your
goals; and (3.) and the chance to make an important contribution to
future patients like yourself by helping us all learn about what
treatments are most effective and offer the best quality of life.
How do I
know whether I can enroll clinical trial?
All clinical trials have inclusion criteria, guidelines
about who can and cannot participate. Please contact us if you are
interested in a certain clinical trial, and we can discuss whether
you meet inclusion criteria. If you are interested in a clinical
trial, we recommend that you discuss this with your cancer doctor
(quite likely, your oncologist) and other physicians before
How safe is
a clinical trial?
All clinical trials are evaluated by a team called the
Institutional Review Board (also known as the “IRB”. The IRB helps
to ensure that the treatment program offered is reasonably safe. The
IRB often consists of doctors, nurses, scientists, and other experts
in the field. Treatments and drugs used in clinical trials have
often been studied for years in the laboratory and, generally, in
both animals and humans before they become available to clinical
trial participates. Patients who are on a clinical trial are
carefully assessed by their health care team for not only efficacy
but also for evidence of side effects on an on-going basis, usually
until the end of the clinical trial. While to measures discussed
above are designed to protect patients, there is always some level
of risk. The risks and benefits of any clinical are discussed in
plain English in your consent form. It is important that you
understand these before enrolling.
research help me personally? Will I get a “sugar pill”?
A clinical trial may give you the opportunity to try an
emerging treatment or drug, often before it is widely available.
While the clinical trial may give you this opportunity, it does not
guarantee this opportunity. In some trials, patients can be randomly
assigned to the control group, the group that gets standard,
currently-used therapies. Please keep in mind that patients in the
control group often get the best known currently-used therapy. In
some cases, when there is no known useful therapy, patients in the
control group may receive a placebo.
How will I
know about the benefits and risks?
It is important to know the potential risks and benefits
of any clinical trial. These are listed in a portion of the protocol
known as the “informed consent”. Please ask all questions that you
may have and be sure that you understand the treatment protocol
What if I
change my mind?
You give your consent to go forward with any clinical
trial before enrolling. Should you later change your mind, it is
your right to drop out.
Where can I
find out about more about clinical trials?
There is a large database of clinical trials offered all
around the country at the National Institute of Health Website. You
can reach this at www.clinicaltrials.gov. For the benefit of out
patients, our website EJGH Clinical Trials lists all clinical trials
being offered at the EJGH campus.
Adjuvant, (an Adjuvant therapy is
an extra or additional therapy that is used after the primary
therapy. It is often used to improve upon the cure rate and decrease
the rate of occurence. An example, for instance, is when adjuvant
radiation or adjuvant Tamoxifen is given after surgery for breast
cancer -- both these extra therapies after the main therapy cut the
Antibody, a complex molecule that the human body uses to
recognize certain proteins. Drugs using antibodies can often target
tumor cells very specifically, having relatively little effects on
other healthy tissues. Herceptin ® is an example of an
Biologic, Biologics are a certain type of chemotherapy that
usually act upon a very specific step in the biology of the cancer.
Biologics are made from biologic processes that are adapted to treat
a disease. Biologics include drugs made of DNA, RNA, or proteins.
Herceptin is an example of a biologic.
Blinded/ Double-Blind, a Blinded study is a multiple-arm
study in which the patient and, usually, the investigator do not
know which arm the patient is in. Studies that are blinded provide
great data because the patient or the doctor cannot influence the
Chemotherapy, chemotherapy is a medicine that is used to
treat cancer, usually by killing cancer cells or preventing cancer
cells by growing. Chemotherapy can be used for cure or palliation.
It is generally given intravenously (IV) or by mouth (orally.),
Hormone Therapy, Hormone therapy involves giving a drug that
manipulates a patient’s hormonal levels of treat a cancer. The
hormone therapy is often given orally (such as Arimidex) but can
also be intravenously (such as Faslodex) or intramuscularly (such as
Lupron.) Breast cancer and prostate cancer are often treated with
Neoadjuvant, a neoadjuvant is a form of an adjuvant therapy,
a therapy that is an extra or additional therapy to the primary
therapy. Rather than given after the primary therapy, it is given
before the primary therapy. Examples are breast cancer, in which
chemotherapy can be given before surgery, or rectal cancer, in which
chemoradiation can be given before surgery.
Non-small Cell Lung Cancer (NSCLC), this is the most common
form of lung cancer. Lung adenocarcinomas and squamous cell
carinomas fall into this group.
Melanoma, this is a cancer arising from specialized skin
cells called melanocytes.
Phase I or Phase II, these are the phases when first the
safety and the optimal efficacious dose is determined.
Phase III, This is among the final phases in assessing a new
drug or treatment. In this phase, the efficacy or effectiveness of a
drug is determined by comparing it directly to the standard arm.
Placebo-Controlled, this is a type of a Phase III trial in
which the experimental arm (the new drug or treatment) is compared
against a placebo. This allows careful evaluation of the effect of
the experimental treatment.
Radiation Therapy, this is the use of precise, high-energy
X-rays that can be directed at a tumor or at an area at risk of
cancer spread. Radiation therapy can be used to cure cancer, such as
in the case of prostate cancer or head and neck cancer, or to
palliative or improve upon symptoms such as pain.
Randomized, a randomized trial is one in which some
participants are given one treatment and others a different
treatment, often on a random basis. This allows doctors and
scientists to directly compare the two treatments.
Small Cell Lung Cancer, a form of lung cancer, less common
than small cell lung cancer.
Vaccine, this is a treatment that recruits the body’s own
immune system to fight a tumor.