A clinical trial is a research study involving a select group of people — either healthy volunteers or patients dealing with a disease — who have volunteered to try a new intervention under close medical monitoring.
Clinical trials are crucial for people dealing with cancer, propelling new treatment options and potential cures forward.
Once completed, clinical trials — which are organized into four different phases — answer researchers’ questions about the safety and/or effectiveness of the intervention, such as a new drug, therapy or technology that may save future lives.
Fred Hutch Cancer Center has been running clinical trials to provide better outcomes for patients since its founding. Our physicians know how important these trials are for moving treatment improvements forward.
“Clinical trials are vital to develop new and improved treatments for patients, especially those who have conditions where current treatments don't have the best outcomes,” said radiation oncologist Lia Halasz, MD, who treats brain and central nervous system cancers at Fred Hutch - Proton Therapy. “Clinical trials have led to the great innovations in oncology that we've seen at Fred Hutch over the past decades.”
Yolanda Tseng, MD, MPhil, who leads the clinical trials program for the Radiation Oncology Division at Fred Hutch and the University of Washington, stressed the importance of trials for reducing the toxicity of cancer treatment.
"Clinical trials are the gold standard for us to understand how best to screen, treat and/or follow patients with cancer,” she said. “We want to be able to continually improve outcomes and reduce any negative effects from treatment to the patient.”
Proton therapy patients routinely participate in clinical trials for a variety of cancers. We reached out to get their take on why they chose to join a trial, what the trial experience was like and what they would recommend for people considering a clinical trial.
Ethan Wheeler enrolled in a clinical trial for brain cancer at age 16, believing he had nothing to lose by participating. Wheeler’s trial tested whether a lower dose of radiation would be as effective as the proven, higher doses while reducing short- and long-term side effects. As is always the case before a clinical trial enrolls patients, non-human trials had already shown that this was likely true.
“If I could help other kids have easier treatments, I thought I might as well do it,” he said.
His mother, Jessica Wheeler, had more nuanced feelings.
“I couldn’t help worry that the lower dose might not be as effective,” she said. “Ethan’s doctors had recommended the trial because a lower dose of radiation — delivered via proton therapy — would have fewer negative side effects on his still-developing brain.”
While worrisome, his mother agreed it was a good option to try.
Jane Cho, a Fred Hutch employee and sarcoma patient for the past 16 years, had proton therapy for a previous recurrence. She had similar feelings of uncertainty when she enrolled in a clinical trial to treat a third recurrence last year.
“I was nervous but hopeful,” she said. “I was patient number two of 10 open spots. I felt like I had won the lottery, but I was nervous because there was a risk that this new treatment type wouldn’t be effective. At a third recurrence, my treatment options were starting to be limited. It also felt good to be part of something that could become an approved treatment for others with the same disease."
Gillian McDonald, 33, was diagnosed with rare triple negative stage 3c inflammatory breast cancer after noticing a lump during a breast self-exam.
After learning she had an aggressive type of breast cancer that had already spread to lymph nodes, McDonald decided to participate in several clinical trials, including a proton therapy trial, hoping to find a cure. More than two years post-treatment, she’s doing well.
“I think it’s very important to take part in clinical trials and to be part of the research that may lead to a cure,” she said. “This is how we move medicine forward. For me, it’s been an amazing experience.”
Bob Duncan, who enrolled in a skin cancer clinical trial, also pointed to the importance of advancing treatment options as a reason to participate. Diagnosed with squamous cell carcinoma that grew along the nerves in his face, his trial tested whether combining a type of immunotherapy drug called a checkpoint inhibitor before and after (proton) radiation therapy would enhance doctors’ ability to treat inoperable cancers like his. Currently, all his scans look clear.
“Options used to be limited, but now there are so many,” he said. “It shows we’re successful in treating cancer.”
Sadly, not all patients with cancer are able to survive the disease, although many are able to extend their lives through clinical trials.
One such patient, Liz Kuper, MD, was a Boise, Idaho-based family physician whose metastatic breast cancer advanced to leptomeningeal disease (LMD) earlier this year. In LMD, tumor cells float freely in the cerebrospinal fluid that bathes the brain and spinal cord; it remains a serious complication of metastatic cancer associated with poor prognosis and limited treatment options.
Kuper enrolled in a clinical trial to take advantage of the most up-to-date data regarding proton radiation over traditional radiation for LMD, said her husband, Joe Reitan.
“She had been in treatment for five and a half years doing everything from pill chemotherapy to infusion chemotherapy,” Reitan said. “When Liz found out about the leptomeningeal metastasis, she was starting to struggle with walking, but she really wanted to be able to keep up with our two young kids. As a physician, she was really into the newest and best treatments, and we flew to Seattle to learn more about a trial offered there. By the end of the trial, she was walking again.”
Despite the trial, Kuper died of her disease in mid-2026.
“Definitely more appointments,” said Ethan Wheeler, the patient with brain cancer. “But it wasn't unbearable or anything.”
His mother elaborated on the pre-trial process, which was considerable.
“It was very fast-paced,” she said. “It took almost a year to get a successful diagnosis, but then it was a rush to decide if we wanted to participate in the study. When we did, there were lots of labs and new provider visits to get baseline measurements for things we never thought about, like vision and hearing. He had to get a port for chemotherapy, and we had to decide on the pros and cons for various types, all within 30 days.”
There were also post-treatment checks and psychological-cognitive assessments to track his memory and brain skills, she said.
“It was a whirlwind for our family,” she said
According to her husband, Kuper had chosen to do a trial at Fred Hutch with proton therapy over traditional radiation; a previous clinical trial had shown that patients treated with protons had better disease control and were living longer.
“Overall, we were really happy,” Reitan said. “Some treatments were delayed, and we ended up spending the entire month of May away from home. But in terms of outcomes, we were never able to follow up and see if the radiation did what we wanted in the brain. We felt it did because she was walking after treatment, which she wasn't able to do when we started. But Liz passed away 13 days after leaving Seattle due to LMD.”
Sometimes, being in a trial means trying a brand-new treatment regimen. Cho said the treatment she received was extremely hard on her body, but she was very excited to learn that the intervention being tested in her trial is now FDA-approved because of the promising results.
“I’ve had multiple surgeries, proton radiation and chemotherapy, and this was, by far, the hardest,” she said “The infusions were tough; they caused chills, pain all over and uncontrollable body shakes. I was unable to walk and got winded just standing to brush my teeth. But visits from my 6-year-old son motivated me to recover faster. I pushed myself to walk a little more each day around the halls of the hospital floor. I made a remarkable recovery in a short amount of time. Almost a month after admission, I was discharged. And now I know that my participation helped get this treatment to others suffering with sarcoma.”
Clinicians will often recommend a trial if their patient is a good candidate and could benefit from the new intervention. Engaged patients also look for trials on their own, consulting with their physicians as to whether they qualify (clinical trials often have strict eligibility guidelines).
While there are many factors that determine if a patient can participate, the option to join a trial is always up to them. Since experiences vary, patients should do their own risk assessment on whether participating in a trial is worth it for them.
“Sometimes, there’s a risk of it not working,” Cho said, “but for me, the chance that it would help me and also contribute to science and research felt like a huge win. For me, it was totally worth it, and I have been doing great for the past year.”
Jessica Wheeler agreed that the trial was worthwhile for her son.
“Do your research and weigh the pros and cons,” she advised. “We felt it was worth a shot. At the end of the day, there was never pressure to do the trial. It was an option. We thought it was important to see if we could help bring the dosage down to the safest, lowest level needed to still be effective and help future patients thrive. And Ethan is doing better than we could have hoped. It’s a miracle.”
Reitan felt that his late wife would recommend anything that might have a chance of prolonging life to be with family.
“Trials are great opportunities, but sometimes you need to be aware of potential longer timelines versus doing more traditional treatments,” he said. “Overall, we had a relatively good experience and yes, if there is a trial that could help when traditional treatment isn't working anymore, we would recommend it.”
For many people with cancer, it’s not just about their own survival, but helping others live longer, better lives.
“There is no cure yet for sarcoma,” Cho said, “but I am grateful and hopeful with all the advancements made in cancer research over the last decade that there will be. It has been 16 years, and participating in this trial is buying me more time. It might be the same for others.”
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