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 safe.

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 enrolling.

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.

Will the 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.

Glossary (alphabetical order)

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 recurrence risk.

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 antibody-based drug

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 results.

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 hormonal therapy.

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.