Navigating Clinical Trials in Gynecologic Cancers

Clinical trials play a pivotal role in gynecologic cancers, offering patients innovative therapies while contributing to groundbreaking medical advancements, an expert said during the CURE® Educated Patient® Gynecologic Cancers Summit.

Understanding what a clinical trial is and how they are performed may allow patients to feel safe and hopeful during cancer treatment, said Dr. Sarah Crafton, a gynecologic oncologist at Allegheny Health Network in Pittsburgh, Pennsylvania during her presentation.

"Clinical trials are the research studies that test how well new medical approaches work in people," Crafton noted. "The important thing to emphasize is that it’s a nonspecific definition. It can be about anything in medicine ... prevention, diagnosis, how well treatments work."

A clinical trial is a research study that test new medical approaches in people and provide information including prevention methods, correct diagnosing or the treatment itself.

These trials are then conducted in different phases:

• Preclinical phase: Laboratory testing which provides information on doses and toxicity levels.
• Phase 1: Small number of patients to test safety and dosage.
• Phase 2: Larger group of patients to assess effectiveness and side effects.
• Phase 3: Compares new treatment to standard practices of care.
• Phase 4: Monitors long-term effects after approval.

Phase 1 trials are typically shorter, lasting a few months to a year. Phase 2 and 3 trials can last several months to a few years. Phase 4 trials may continue for many years to monitor for long-term effects.

Why Participate in a Clinical Trial?

Participating in clinical trials offers patients access to new treatments before they’re widely available, Crafton said. Additionally, patients will receive close monitoring by medical professionals, creating a safe and comfortable environment. Participants should also be aware of their contribution to medical advancements through clinical trial participation.

"Clinical trials can be really impactful from the beginning of the time of diagnosis," Crafton said. "…Clinical trials also exist and occur to assess how well surgeries work, different surgery techniques. And these are all things that may happen from the time of diagnosis. So, from the patient perspective, please never think it’s too early or too late to ask your provider about what my trial options may be.”

What to Expect in a Clinical Trial

The first step to participate in a clinical trial is informed consent, which does not only entail paperwork.

“Informed consent is often thought of as a stack of papers that explain a lot of information about the trial, but the informed consent process goes far beyond that paper.”

This process involves conversations and exchanges of information with a patient’s provider and clinical research team.

“This is when you have the opportunity to get information and have your questions asked that talk about why the study is being done, what medication or agent is being used, and why, how long do you expect to be on the trial,” Crafton highlighted. “Importantly, are there any possible risks or discomforts you could experience? What have other patients experienced? And, really, really important, what are the possible benefits?”

Of note, researchers conducting clinical trials put safety as a top priority throughout the duration of the study.

“When you are enrolled on a clinical trial, how we know that medications are working is serially assessing over and over again, all kinds of clinical information, just like when you're seeing your doctor for regular treatment, vital signs, labs, pictures, imaging such as CT scans or MRIs, all of these are ways that we can make sure that you are also continuing to be safe on the trial medications, just like the regular standard of care,” Crafton stated.

Finding a Clinical Trial

Crafton urged patients to ask their oncologist about clinical trial opportunities at any time during a cancer diagnosis and treatment.

“From the time of diagnosis or through the entire disease course, keep an open dialogue with your provider, and constantly ask about what trials exist,” she added. “If not at that institution, are there any institutions nearby that they can be screened for trials?”

In addition to patients talking to their oncologists, they may search the internet for information regarding clinical trials that may fit their eligibility criteria. Websites such as ClinicalTrials.gov are helpful for this purpose, Crafton said.

“This is a public website,” she noted. “Anyone can look things up on it. And … you can type in the disease you’re looking for. You can type in the location and filter by mileage in order to find trials open near you. This is something your provider can do, but you, as the patient, can also look for.”

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