Clinical Trials

What are Clinical Trials?

Clinical Trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. The primary goals of all clinical trials are:

  • To find better treatment to fight cancer that are more successful
  • To improve the treatment of side effects resulting from cancer therapies

Clinical research is the process by which new treatments are approved by the FDA (Food and Drug Administration) for use in the general public. Before a medication or procedure can be FDA approved, it must be tested to make sure that it is safe and effective. All cancer and supportive care drugs in use today were approved by the same process.

Should I Consider a Clinical Trial?

Over the years, thousands of people have benefited from clinical trials. Some people have extended their lives by participating in clinical trials. Oftentimes people in studies get promising medical treatments that would not be available to them by any other means. However, there are risks and possible side effects to consider. For instance, it is not clear how a new treatment will work for each individual. In some cases, patients have had negative reactions to a new treatment.

There are also trials available know as observational trials where only the consent of a patient is needed to participate. The goal of an observational trial is to gather as much information about a patient’s medical history so that researchers are able to obtain a better understanding of how medicine can be improved.

It is up to you, your doctor, and your family to decide if a clinical trial is right for you. Patients who are interested in participating go through a process called screening. The purpose of the screening process is to determine if the patient meets the necessary criteria. These criteria define who is eligible to enroll in a trial. If you are eligible and your doctor thinks it is in your best interest, you will be given the option of trial participation.

Your participation in a clinical trial is completely voluntary and you may revoke your participation at any time. You will not be placed in a clinical trial without your signed informed consent.

How will I know if I am eligible?

At the time of your scheduled visits, our doctors will discuss your diagnosis and treatment options. If there is a clinical trial being conducted at our office that you may be eligible for, your doctor and/or the research staff will talk with you. Please do not hesitate to mention clinical trial participation at your visit if you are interested. Ask about any clinical trial that may be an option for you. Be your own advocate!

How can I find out more information concerning Clinical Trials?

Brittany Horst, RD is the clinical trials coordinator for this office.  She is available to answer any questions or concerns you may have and can be reached at 717-291-1313 ext. 116, Monday-Friday 8:30 a.m. to 4:30 p.m.

Additional information on clinical trials can be viewed online at:

National Cancer Institute — Clinical Trials

www.clinicaltrials.gov

www.cancer.gov

www.fda.gov/drugs/informationondrugs/approveddrugs

www.cancer.net/preact

 

Almost since its beginning, the physicians at the Lancaster Cancer Center have offered select clinical trials to our patients. Clinical trials offer two distinct opportunities to patients. First, certain qualifying patients will gain access to cutting edge treatments not otherwise available. Second, all participating patients will be able to contribute to scientific research and the ongoing fight against cancer.

Patients participating in clinical trials at the Lancaster Cancer Center always receive treatment for their disease. Some patients may be eligible to participate in treatment trials. Such trials might involve a new drug, a new dosing schedule of an established drug, or a new combination of established drugs. These treatments are used in our office only after completing the extensive clinical trials process overseen by the Food and Drug Administration. Other patients may be eligible to participate in observational trials. Such patients receive established treatments while contributing anonymous data on their progress.

Whether patients choose to participate in a clinical trial or not, they know that they are receiving the best care possible at Lancaster Cancer Center. Patients who do choose to participate in clinical trials also know they are contributing to our knowledge of and ability to combat cancer in all its forms.

Definition of Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Current Clinical Trials at the Lancaster Cancer Center

ASK YOUR PHYSICIAN IF YOU ARE A CANDIDATE FOR ANY OF THE TRIALS LISTED BELOW.

  • CONNECT MDS/AML REGISTRY – A disease registry trial for patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). ClinicalTrials.gov Identifier: NCT01688011
  • INFORM CLL REGISTRY – A Disease Registry for Patients with Chronic Lymphocytic Leukemia. ClinicalTrials.gov Identifier: NCT02582879
  • INSPIRE Trial – Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients after Failure of an HMA Treatment. ClinicalTrials.gov Identifier: NCT02562443
  • Javelin Lung 100 – Avelumab in First-line Non-small Cell Lung Cancer Stage IV. ClinicalTrials.gov Identifier: NCT02576574
  • NILE Trial – Non-invasive versus Invasive Lung Evaluation for patients diagnosed with Non-squamous, Non-small cell lung cancer.
  • POLARIS Trial – A registry observing the use of Palbociclib in hormone receptor positive, HER2 negative advanced breast cancer.