Exploring Your Options By Looking Into Clinical Trails
- A recent, small clinical trial for a the use of an immunotherapy drug called dostarlimab in a specific subtype of rectal cancer patients is showing exciting results. But one of our experts says the results from the “excellent study” won’t “benefit most of the rectal cancers treated.”
- Clinical trials are research studies that compare the most effective known treatment for a specific type or stage of cancer with a new approach. They can give patients access to incredible new therapies, but they’re not for everyone and the treatments may very well not work for you.
- To help you explore your clinical trial options, SurvivorNet created the SurvivorNet Clinical Trial Finder – an A.I. driven tool that’s built on top of clinicaltrials.gov and gives access to more than 100,000+ individual clinical trials, updated daily.
In a study recently published by the New England Journal of Medicine, 12 patients with a specific type of stage 2 or 3 rectal cancer completed treatment with an immunotherapy drug called dostarlimab. All 12 have undergone at least 6 months of follow-up and shown a clinical complete response with no evidence of disease remaining. Additionally, the success of the immunotherapy drug on these patients meant that they haven’t needed the standard treatments of radiation, surgery or chemotherapy.Read More
In fact, Memorial Sloan Kettering Cancer Center only puts that number of rectal cancer patients with the specific stage 2 or 3 cancers – mismatch repair-deficient (MMRd) rectal cancers – at 5 and 10 percent of all people with rectal cancer. Even still, there is hope to be had, according to Dr. Yeo.
“That said, these anti-PD-1 checkpoint inhibitors are being used in Europe – some studies came out last year – and will be used more and more in mismatch repair deficient tumors,” she said. “The results are exciting, but unfortunately not going to help most patients with Rectal cancer.”
The study is still ongoing, and researchers from MSK are encouraging rectal cancer patients to see if they qualify to join the study.
“Our message is: Get tested if you have rectal cancer to see if the tumor is MMRd,” medical oncologist and study investigator Dr. Luis Diaz, Jr. said in a piece for MSK. “No matter what stage the cancer is, we have a trial at MSK that may help you.”
But that then begs the question for all cancer patients – how do you know you’re getting the best treatment option for your specific cancer? And when are clinical trials – such as the one above – the right move to make?
Understanding Clinical Trials
Well, for starters, let’s taker a deeper look at what clinical trials actually are. Generally speaking, clinical trials are research studies that compare the most effective known treatment for a specific type or stage of cancer with a new approach.
Clinical trials can be an option for people with cancer at many stages of their treatment journey. If you have an advanced disease or there’s a drug that currently considered investigational but may work better than the current standard of care, your doctor may have spoken with you about possibly enrolling in a trial. Even still, you should always feel free to ask a medical professional about clinical trial options if you’re curious.
Pros and Cons of Clinical Trials
All new drugs have to go through clinical trials before the The United States Food and Drug Administration will approve them, and these trials do give people special access to potentially life-saving treatments, though this is not always the case.
Dr. Beth Karlan, a gynecologic oncologist with UCLA Health, previously told SurvivorNet that clinical trials can play an important role for some patients’ treatment, but they also serve a larger purpose.
“Clinical trials hopefully can benefit you, but it’s also providing very, very vital information to the whole scientific community about the effectiveness of these treatments,” Dr. Karlan said. “We need everyone to be partners with us if we’re ever going to truly cure cancer or prevent people from having to die from cancer.”
That being said, there is no guarantee you’ll receive more effective treatment than the standard of care, and clinical trials certainly aren’t right for everyone. You should always talk with your doctor(s) before getting involved in one. Some risks to consider are:
- The risk of harm and/or side effects due to experimental treatments
- Researchers may be unaware of some potential side effects for experimental treatments
- The treatment may not work for you, even if it has worked for others
What Is Informed Consent?
Informed consent process for a clinical trial is when the research team presents you with both standard consent forms as well as any other relevant information you might need regarding treatments so you can properly decide whether you wish to take part in the trial or stay in one if you’re already enrolled.
Before you enroll in a trial, you must be given the opportunity to read the consent documents fully and ask any questions you may have. The documents will likely contain the following:
- The purpose of the research
- Any risks and benefits expected from the research
- Information about procedures that may cause discomfort (like frequent blood tests)
- Any alternative procedures the patient might consider instead
- How the patient’s information will be kept private
- How long the study is expected to take
- A form confirming you are participating in research voluntarily
- Whether any compensation or additional medical care is available if some sort of injury occurs
- The patient’s rights (like the right to stop research in the middle of the trial)
- Contacts for any patient questions
It’s important to remember that participants are allowed to walk away from a trial at any given time. If researchers make new discoveries while you’re participating, they may ask you to sign a new consent form or you may decide to no longer take part in the trial.
Overall, it’s crucial you understand your rights as a voluntary patient and remember that the the treatment may not work before you sign on.
What If You’re Not Eligible?
Trials have specific criteria that patients need to meet in order to take part, so there will always be certain factors for inclusion and exclusion.
But even if you’re ineligible for a clinical trial you wish to partake in, you might still have options. The U.S. passed something called “Right to Try” legislation a few years ago which gives terminally ill people access to highly experimental drugs that are in “phase one” of the clinical trial process.
Your doctor may also request access to a single patient IND (investigational new drug) on your behalf, which can also give access to treatments the FDA has not yet approved.
The SurvivorNet Solution
Whether you’ve already decided that a clinical trial is right for you or you’re just beginning to explore your treatment options, you should know that SurvivorNet has a new tool for you. Introducing the SurvivorNet Clinical Trial Finder: an A.I. driven tool for patients to find clinical trial options for treatment.
The tool, which launched earlier this month, is built on top of clinicaltrials.gov – a database maintained by the U.S. government that compiles privately and publicly funded clinical trials conducted around the world – and gives access to more than 100,000+ individual clinical trials, updated daily.
To use the SurvivorNet Clinical Trial Finder, simply answer some basic questions using our custom-designed chat feature and we’ll send customized clinical trial options within your region right to your email. In simplifying the search, we hope to offer multiple opportunities for clinical trial sponsors and clinical research organizations to engage with patients.
“Clinical trials are critical to the development of new therapies, and as we live through this extraordinary revolution in genomics, immunotherapy and targeted therapy, it’s clear that one of the most pressing needs for patients, clinical trials sponsors, and researchers is simply a better way to find patients,” SurvivorNet CEO Steve Alperin said. “Even one percent more people successfully enrolled in clinical trials can change the world.”
Contributing: Laura Gesualdi-Gilmore