If you have been diagnosed with cancer, you might be thinking about taking part in a clinical trial. What are some important questions you should ask before beginning?

BMC offers a number of clinical trials specifically for cancer patients. Promising new techniques in the diagnosis, treatment, and care of patients with cancer are tested in these studies. If you have received a cancer diagnosis, you may be eligible for a clinical trial to treat the condition.

Dr. Matthew Kulke, Chief of Hematology and Oncology, discusses clinical trials for cancer available at Boston Medical Center.

Featured Speaker:

Matthew Kulke, MD

Dr. Kulke is BMC's Chief of Hematology and Oncology. He is a leader in the research and treatment of neuroendocrine tumors, he has received numerous awards for his accomplishments as a clinical investigator and provider of compassionate care to patients. He has led national and international clinical trials to identify new therapeutic and diagnostic approaches to neuroendocrine tumors and gastrointestinal malignancies.

Learn more about Matthew Kulke, MD


Melanie Cole (Host): If you have been diagnosed with cancer, you might be thinking about taking part in a clinical trial. What are some important questions you should ask before beginning? Here to explain the process of clinical trials is my guest, Dr. Matthew Kulke. He’s a medical oncologist and the Chief of Hematology Oncology at Boston Medical Center. So, Dr. Kulke, what is a clinical trial? Let’s just start with the definition of what it is and who are they really intended for?

Matthew Kulke, MD (Guest): Well clinical trials are a way that we evaluate new drugs that are becoming available and in cancer, there have just been an incredible number of new developments over the past several years. A large number of new and really very exciting new treatments that have been transforming the face of cancer. They have really improved outcomes. All of these new treatments were first evaluated in clinical trials and these are trials again, in which the new drugs are evaluated. We look to see how well they work in our cancer patients and those drugs that are successful; then ultimately become standard of care. They become FDA approved and then more widely available to patients everywhere. 

Melanie: Then let’s clear up some of the myths and fears Dr. Kulke, with clinical trials that people might have. What are some of the most common concerns that you hear, things like am I going to get a placebo and if this doesn’t work, nothing else will? Can you be in a clinical trial while undergoing other forms of treatment? Speak about some of the things that people have concerns about.

Dr. Kulke: Well one of the things that is important to remember is that every clinical trial is different. At the very early stages of a clinical trial, the truth is we don’t really know if the treatment is going to work or not and that’s why the clinical trial is being done. Very often in these earlier stage clinical trials; every single patient is getting the treatment and the objective is really to figure out just how well it works and also to be sure that it’s reasonably well-tolerated. In some of the later stage clinical trials and drugs that have already gone through those early stages; there may well be a placebo-controlled trial or a trial in which a new drug is compared to the standard treatment, what we call the standard of care. So, every trial is different, and the purposes of these studies can really vary depending on the circumstances. 

Melanie: So, what about your current provider? Are they involved with you once you do join a clinical trial?

Dr. Kulke: Well, many trials are done at academic medical centers, just like Boston Medical Center. Our patients have oncologists here that are caring for them, that are responsible for many aspects if not all aspects of their care. Those same oncologists are also the ones that are involved in the clinical trial and would be helping patients get through the clinical trial and also will be talking to our patients about the risks and benefits and what the purpose of the clinical trial is. 

Melanie: How does somebody join a clinical trial? What’s the process and speak about who is involved, the multidisciplinary care for the patient as they go through that process of applying to be in a clinical trial?

Dr. Kulke: Well cancer patients very often will come in and cancer is a challenge and we employ all kinds of things to fight cancer; that includes radiation therapy, that include surgery, and that includes oncology where in many cases we are talking about chemotherapy. Clinical trials can really involve all of those different aspects. They can involve radiation therapy, sometimes they involve surgery and in many cases; they do involve chemotherapy drugs or these days some of the very new promising drugs like targeted therapies and even immunotherapy. 

Melanie: So, are there any risks to joining a clinical trial?

Dr. Kulke: There are risks. In part, the risks at least in the early stage studies are that we don’t really know whether the drug will work, and we don’t always understand the side effects. So, it is entirely possible that the new treatment may not work and it’s possible that the new treatment will result in side effects that are unexpected and that may not occur with a standard treatment. The flip side of a clinical trial is that the drugs that enter trials in many cases, are the most promising new cancer treatment and what we are really looking to do is advance cancer treatments to improve outcomes. So, in many respects, clinical trials are the way that patients can access some of the newest and most promising cancer drugs that are being developed. 

Melanie: So, where does insurance fit into this picture doctor, as far as a clinical trial obviously, people look to their insurance to help them with cancer treatment? Is there any difference with insurance if they are enrolled in a clinical trial?

Dr. Kulke: Well one principle that is very important and that we take very seriously is that no patient should have to pay extra in order to enroll in a clinical trial. So, in many cases, some of the standard things that we would be doing anyway like blood draws or clinic visits are no different than what a patient would get in regular care and those are paid for by insurance. We are very cautious and it’s very important to us to be sure that anything that is considered investigational, that would be above and beyond the standard treatment; is paid for through other means and that may be by the study sponsor which could be a pharmaceutical company, in many cases, that is the National Cancer Institute which also funds and sponsors clinical trials. 

Melanie: Doctor, what about when? When should somebody think about participating in a clinical trial? If they have been diagnosed with stage one or two or three or four type of cancer; is it towards the later stages, after they have already tried traditional forms of treatment chemo, radiation, surgery or can people with stage one some kind of cancer also apply for clinical – what do you recommend?

Dr. Kulke: Well, there are again, many different kinds of clinical trials and as you mentioned, it’s a common perception that clinical trials are experimental therapy, should only be considered at the very last stages when there is no other treatment available. And it’s true, there are clinical trials for patients in that type of situation. But it’s also important to remember that clinical trials are really intended to identify treatments that will be better than the current treatment and that could be at any stage of your treatment course. So, in fact, there may well be clinical trials as the very first line of cancer treatment and all the way through second, third and fourth line treatment, may have available clinical trials that patient could consider. So, again, trials can be considered really at any point in your cancer care. 

Melanie: Wow, it’s such a fascinating topic, clinical trials and all the great work that you doctors are doing and researchers coming up with all of these new things. Give us a little bit of a wrap up, a summary of what you want the listeners to take away from this segment about clinical trials, about asking their provider about whether or not they are eligible for any of these and how they are helping others who might have the same condition in the future by helping to advance cancer research. 

Dr. Kulke: Well clinical trials are really an important part of cancer care. Cancer is a really tough challenge and it remains a tough challenge for us even in the setting of many of the new treatments that have become available. At the same time, cancer care really has been markedly improved and transformed by some of the very new and very exciting new cancer treatments that have become available. Those new treatments have become available because of clinical trials and in fact, many patients can get treated with some of these new and promising therapies, even before they become more widely available. That doesn’t always mean that we know exactly what those treatments are going to do, and it is definitely important to have a discussion with your oncologist about whether a clinical trial is appropriate and right for you. But we do think that it is a really important option for patients to at least have the ability to access some of the new and promising therapies that are coming down the line. 

Melanie: Thank you so much Dr. Kulke, for being with us today. It’s really such great information and helps clear up some of the misconceptions and confusion surrounding enrolling in a clinical trial. Thanks again for joining us. This is Boston Med Talks with Boston Medical Center. For more information you can go to www.bmc.org, that’s www.bmc.org. This is Melanie Cole. Thanks so much for listening.