Clinical Trials for Pancreatic Cancer

The National Comprehensive Cancer Network (NCCN), of the United States, recommends that patients with pancreatic cancer, in consultation with their treating physician, consider clinical trials as potential treatment options. People often think that clinical trials are only recommended for patients with advanced cancer as a last option for those not responding to treatment, but this is not the case. Clinical trials exist for all stages of pancreatic cancer and include chemotherapy agents, immunotherapy agents, and targeted therapies.

Even though there are many approved treatments for pancreatic cancer, there are some instances when an investigational drug available in a clinical trial may be among the best options. Cancer treatments such as chemotherapy and radiation are used in addition to surgery or when surgery is not possible. Cancer treatments are used to kill cancer cells, shrink tumors, and reduce the chance of cancer recurrence. NCCN guidelines state that clinical trial cancer treatments are the preferred option for some patients. This includes treatment to prevent recurrence after having a pancreatic tumor removed and as a treatment for recurrent pancreatic cancer.

Clinical trials

Clinical trials are research studies that evaluate if a drug is safe and effective. There are specific guidelines about who can participate. Clinical trials are designed to investigate new ways to treat, diagnose, prevent, or manage symptoms of cancer as well as side effects from cancer treatments.

Before a clinical trial even begins, many years of pre-clinical research have already taken place in the laboratory setting. This research establishes much of the knowledge about how the investigational treatment works and which side effects it may cause. Clinical research studies must show that the treatment is safe and effective in people in a clinical trial before it is approved by governments and can be used to treat the general patient population.

Every clinical trial has a person in charge, called the principal investigator. The principal investigator, usually a doctor, designs the trial protocol. The clinical trial protocol contains the procedures and other information that helps them choose participants that are best for a particular trial. For example, the clinical trial protocol will contain the reason for doing the trial, eligibility criteria, how many total people are needed, the drug treatment and dose as well as details about medical tests and data collection. All of this information helps the principal investigator and your doctor decide if the clinical trial is right for you.

In some clinical trials patients are randomized into treatment groups and the participant and their doctor do not know which treatment they are receiving. In open-label clinical trials, the participant and doctor know which treatment is being received.

Clinical trials are completed in phases where each subsequent phase builds on the previous one. The phases of cancer clinical trials are organized as follows:

• Phase 1 trials evaluate safety and side effects
• Phase 2 trials evaluate how well the drug or approach works for a specific type of cancer
• Phase 3 trials compare the drug or approach to the standard treatment and can result in government approval
• Phase 4 trials study an approved treatment for long-term safety and benefit

Why join a clinical trial?

For the patient, clinical trials offer an opportunity to be treated with a cancer treatment that is not yet widely available. Some people worry that if they join a clinical trial they might receive a placebo and miss out on treatment. In cancer clinical trials, participants not receiving the investigational drug receive the commonly used or standard cancer treatment. A person who enrolls in a cancer clinical trial may receive the standard treatment, the investigational drug, or both.

New drugs receive government approval for use after they have been shown to be safe and effective in clinical trials. Thanks to clinical trials, we have successful cancer treatments that are helping people live longer lives. Clinical trials are the way researchers determine if new treatments are safe and effective and if they work better than current treatments. By participating in a clinical trial, you can add new knowledge about cancer and help make better cancer treatments available for future patients.

Keeping patients safe in clinical trials

There are risks to taking part in a clinical trial but participants are closely monitored. In the process of obtaining informed consent, you are given information about possible risks and benefits to help you decide if the clinical trial is right for you. Researchers will provide detailed information that you should read carefully and ask questions before deciding. You must make an informed decision in consultation with your doctor.

Eligibility criteria may be based on age, cancer type, and stage, treatment history, or general health. They help keep participants as safe as possible and also ensure that participants are alike in specific ways so the results of the study can be evaluated clearly.

The clinical trial protocol is reviewed by scientific experts and an institutional review board (IRB). An IRB is composed of scientists, doctors, clergy, and patient advocates who review and approve the protocol. The role of the IRB is to protect people taking part in a clinical trial by making sure the clinical trial is well designed, legal, and ethical, and does not create unnecessary risks.

Throughout the clinical trial, participants are monitored by the IRB, the organization that sponsors the trial, and the research team. Phase 3 trials are monitored by additional Data and Safety Monitoring Boards (DSMBs). Once a clinical trial begins, patients are still free to stop participating for any reason. Patients will be made aware if new information arises that could affect their decision to continue.

People with pancreatic cancer should consider both approved cancer treatments and investigational drugs that may be available to them in clinical trials. You do not need to wait for your doctor to bring up the topic of clinical trials. You can start the conversation by asking your doctor about clinical trial options or if you know of a potential clinical trial ask them to check if you are eligible.

myTomorrows is dedicated to helping patients with pancreatic cancer find and access clinical trials and other possible treatment options. Find out how here.