Gynecologic Cancer Clinical Trials: What This Means for You



when you've been diagnosed with a gynecologic cancer you may find yourself in unfamiliar territory every step of the way there are decisions to be made knowing your options can be a breath of fresh air in the midst of cancer treatment whether you've been newly diagnosed or have undergone several different therapies and joining a clinical trial is another choice that you can make because they had gotten all the cancer and I thought why you know I'm out of the woods but she was like well no because ovarian cancer comes back usually even if you have a good you know a good response to treatment and so she gave me I believe was like ten to their twenty to thirty percent chance of being around him five years and I thought that's not good enough because I have a thirteen year old daughter and I'm not I'm not gonna put up with that my diagnosis was laiá laiá sarcoma it's a rare soft tissue cancer that was found in my uterus I had never heard of leiomyosarcoma and to this day I still even have a hard time explaining to people what exactly it is because it's not common at all clinical trial is an opportunity for a patient to obtain access to drugs that might not be on the market so as you can imagine any time someone faces a cancer diagnosis we can run out of standard of care treatments that are effective for the patient when that happens it's really nice to offer to the to a patient if they're interested the opportunity to use an experimental medication when I sit with the patient for a clinical trial i define what is the goal of the clinical trial and clearly I describe the protocol and I discuss the side effects related to to clinical trials I think it's really important to remember that any clinical trial is based on a bedrock of laboratory investigation we don't get to a clinical trial without a tremendous amount of effort in the laboratory that requires resources energy horsepower intellect all of that like any major life decision deciding to enroll in a clinical trial involves weighing risks and benefits and overcoming misconceptions patients are sometimes leery about participating in clinical trials because they think they're being quotes like guinea pigs and so we want to reassure them that that's not the case that they're getting ZAR the standard treatment but they may have an opportunity to get another drug or a different treatment that may enhance their chances of responding or being cured I suppose the biggest misconception I hear is that a clinical trial is only after every other drug has failed and this isn't true clinical trials vary some clinical trials are designed to be the first treatment other clinical trials are designed after two treatments it varies a lot many of the larger clinical trials are confirmatory trials and maybe rather than proof-of-concept are actually looking for the perfect dose or the perfect duration of treatment so we might actually be able to really tell the patient with some accuracy what to expect your doctor can help you identify the clinical trial opportunity that is most in line with your goals historically fear there has been negative feelings about clinical trials but not not in my my family or or with me but I do understand that there is this this hesitancy it's important for you and your doctor to have an honest conversation about the risks and potential benefits of a clinical trial new drugs and procedures may have side effects they may be ineffective or less effective than current treatments and even if the new treatment has benefits it may not work for you personally there's no guarantee but it is an opportunity and you are watched and monitored throughout the process and you're part of the decision you're not just a passive person who's going through kind of control you do have to say so and they should know that that there are numerous safety stopgaps built into a clinical trial so that if they are not doing well if they're experiencing too much toxicity if they just feel like they can't continue on for whatever reason they have the opportunity to withdraw as far as potential benefits are concerned women who participate in gynecologic cancer clinical trials have access to new drugs and interventions before they are widely available clinical trials nurses will be on hand to answer your questions and gynecologic cancer researchers will be closely monitoring your health and any side effects if the approach being studied is found to be helpful you may be among the first to benefit in the laboratory have very limited systems sericulture and we cannot really predict very accurately how good a novel treatment works so we didn't need a real-world setting to test any treatments modern chemotherapy regimens but the guy not doctors are using every day for new patients all were discovered and validated through large clinical trials that required a lot of participation participation from willing patients to understand what is really going to improve survival if you feel that the medical benefits outweigh the risks you may still have questions about how a clinical trial will impact your daily life in the consent form should be very very well laid out what the insurance company will be responsible for what's considered standard of care versus what's considered under the purview of the clinical trial that should be covered by the trial itself when we've had a lot of conversations around you know the the effort that it's going to take to be in the trial and you know how much traveler is gonna be how much that's gonna weigh on our family and taking care of our daughter and they're you know what the financial cost of it are gonna be we agreed you know that we would take this on as a family and you know get help from parents and siblings and friends to watch our daughter and help make it work you know like one out is normal really as far as I can see I'd get a little crabby but [Laughter] clinical trials are an option at any stage of treatment from initial diagnosis to recurrence to survivorship when considering a clinical trial it is helpful to understand the different phases of clinical trials that might be involved in your treatment phase one trials are usually the first step in testing a new therapy in human beings and usually involve twenty to forty patients these early trials are designed to study the safety of a new therapy as well as how the treatment is processed in the body this helps scientists determine the best dose for the new treatment people with many kinds of cancer can participate in Phase one clinical trials and often it does not matter how many treatments you have completed previously if the scientists find the new treatment is effective in treating a particular kind of cancer the next step is to test it in a Phase two trial phase two trials test how well the therapy works on a specific kind of cancer also known as clinical efficacy whether you are eligible for participation may depend upon how many treatments you have had in the past these trials involve a larger number of participants usually between twenty-five and a hundred patients phase three clinical trials compare the clinical efficacy of the new treatment against the current standard treatment enrollment can range from 100 to 1000 patients your doctor can help you decide what phase of clinical trial best suits your needs I think people need to understand on the very sad end of our work is that in general we can't do clinical trials in the very last stages of life it's not possible to test an experimental drug on somebody who is bed bound and in severe pain or whose kidneys and liver are no longer functioning so that isn't the time when we want people to first be thinking about a clinical trial sometimes clinical trials are randomized which means your treatment plan will be assigned randomly to you like the toss of a coin the treatment plan assigned to you may be the experimental therapy or might be a well-established regimen being used for comparison sometimes a placebo is used for comparison a placebo is a treatment that looks just like the study treatment but does not have the active ingredient like a sugar pill although there are investigational trials where one treatment may be compared against a placebo the vast majority of trials utilizing placebos add the placebo to treatments that are known to be effective for example one treatment is known to be effective in treating cancer but a new drug given with this treatment might be more effective a study designed to see if the two drugs are better than the one alone might compare these treatments with the original drug plus a placebo in this kind of study everyone who participates gets active treatment and I signed the paperwork I did see that there was a possibility of a placebo but I knew that I also was going to have traditional treatment as well so this would be a complement to that treatment that's the way I view the clinical trial is that it would be a complement to it and I could proceed on from there so I didn't have problems with that to ensure the most reliable results researchers want study participants to be alike in certain ways this may include the type of gynecologic cancer cancer stage patient age previous treatments specific gene mutations and other health considerations like heart disease or diabetes the way the process went would be for my clinical particulars to be forwarded to a tumor board so I learned some new language that was a new term for me and the tumor board would review my profile and including other diagnostics that were required like thyroid you know labs and determine my eligibility to participate in this trial a multidisciplinary care conference also known as a tumor board is a really a terrific way to be able to get what extra opinions and detailed insights until you know the best steps for a patient and it are two rewards one of the things that we always discuss this might a clinical trial be best for this particular patient at this particular time or not and what clinical trials do we have available so that's discussed amongst the radiation doctors the surgeons and the medical oncologists all of whom might have different thoughts about and different knowledge about what's available joining a clinical trial usually requires additional hospital visits to obtain medications and monitor progress so every patient that comes here not only sees B but they also see some other member of our healthcare team usually more than one other member that may be a medical student a resident a fellow a nurse practitioner we have clinical care coordinators that help us run our clinical trials we have a variety of people that kind of address their needs social workers nutritionists so and then we have a group of nurses in our infusion center who get them the chemotherapy and address that issues related to toxicity from the drugs or whatever treatment they're getting in my case or in any case in this particular study there are monthly surveillance exams with dr. Lorraine and that includes a physical exam self reporting and review of the Diagnostics outport draw labs and all of this is done every month which would be any cancer survivors dream to be surveilled to such an extent that often would be a gift for patients who live farther away from comprehensive cancer care centers there are ways to overcome the distance no one in a rural area is looking to add a commute parking and the other stressors of coming to a Cancer Center to their cancer treatment regimen that said we are living in a day of oral chemotherapy not exclusively of course but many trials right now include an oral chemotherapy component so that can mean that some things are done closer to home and they're not coming in for infusions many times we can order laboratory studies and imaging studies at hospitals or clinics closer to where the patient lives while the ultimate goal of cancer treatment is to cure the disease sometimes the most realistic goal is to ensure the best quality of life for as long as possible even with advanced disease with a poor prognosis clinical trials can offer patients the gift of more time everything that I've ever wanted to do I've accomplished I went back to school during those 18 years I always wanted to be a physical therapist assistant I was able to obtain that goal I've been to Italy three times and I mean I would never have guessed that I would have been able to do that 18 years ago I don't know that there are a typical treatment plan out there that could that we could see benefits from so I think these having these opportunities has kept our fight going longer yeah I agree with that I mean I think it's been almost five years since since you've been diagnosed and I think you know a large part of you know why we're here having this conversation is because of the clinical trials that she's been a part of to keep hope alive for the thousands of women impacted by gynecologic cancers each year the foundation for women's cancer provides grants and awards to researchers to conduct studies that may lead to advances in gynecologic cancer treatment thanks to this research and the donors who support it women with gynecologic cancers have more treatment choices and using online resources finding a clinical trial is much easier than it was in the past but challenges remain in cancer research funding and patients of all backgrounds are needed to present a true picture of how well new treatments work in the United States there is tremendous disparity in health care based on race ethnicity sometimes gender education level and as it relates to clinical trials I think the onus is on all of us is all of us to offer all women clinical trials no matter Koller education ethnicity doesn't matter it is important to know you have options and the choice to join a clinical trial may be the right option for you you get this opportunity to participate in a clinical trial where you're saying that I made a difference and so therefore you're not only empowered but you're saying that it mattered I mattered I participated in a clinical trial and I mattered not only in my own health but in others as well because I've always have been a participant and that's something that so I can't take from you when I take my tablets twice a day I may be taking them by myself but I am NOT alone because all of the effort the energy the intention the desire of a plan the background the training of brilliant people whether they are the researchers or my medical team everyone had a role in my amazingly good outcome map out your treatment options and talk to your doctor about joining a clinical trial you

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