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NIH MedlinePlus the Magazine, Trusted Health Information from the National Institutes of Health

Feature:
Clinical Trials

Clinical Trial Results Vary Widely, But Always Advance Research

Clair Nelson

Clair Nelson is healthy and happy, two years after entering a clinical trial for cancer.
Photo: Clair Nelson

By Christopher Klose

Suffering from advanced esophageal cancer, Clair Nelson, 66, joined a Phase I clinical trial. (See "Phases," page 5.) Although few clinical trials provide immediate cures, Nelson was found cancer-free two months later because of the experimental medical treatments.

"They found the tumor in my throat. It was about three-and-a-half inches in diameter, and inoperable—Stage IV esophageal cancer," says Clair Nelson, 66, of Chattanooga, Tenn. "My oncologist offered me two choices: palliative care (pain and symptom relief) for, if I was lucky, two years, or a clinical trial.

"It took two seconds. I chose the clinical trial. It wasn't a hard decision," he smiles. That was February 5, 2008, at Vanderbilt-Ingram Cancer Center, in Nashville, Tenn.

Less than two weeks later, he was enrolled in a Phase 1 clinical trial at the Duke Esophageal Cancer Clinic, part of Duke Medicine in Durham, N.C. The goal was to shrink the tumor enough so that it could be removed surgically.

Under the care of principal investigator Brian Czito, M.D., over a six-week period Nelson received 28 radiation treatments and a combination of three powerful drugs. The third drug had never been used to treat esophageal cancer before.

Then, in April, Nelson and family members met with his surgeon to learn the results: 'When we first met, I told you it was inoperable. Well, you're still inoperable. The tumor's gone!' my doctor said," Nelson recalls. "It was very emotional."

Should You Be Interested in a Clinical Trial

People volunteer to take part in clinical trials for many reasons. Often, they hope that by participating, their health will benefit in some way.

Researchers are comparing different treatments to determine which is better—for example, more effective or less risky. Sometimes the newer treatment is better, and sometimes the standard treatment is better. The study is being done because it's not yet known which one is better.

Clinical trials can entail risks that must be disclosed to potential participants as part of the informed consent process prior to enrollment. Always discuss a clinical trial with your health professional before participating.

Many times, people volunteer simply because they want to contribute to a medical research effort that may help others in the future.

—Source: MedlinePlus.gov; Patient Education Institute

Since then, he has become a strong and vocal advocate for clinical research trials. "The level of care is top-notch and 24/7," he reports. "Everyone wants to know there's hope, and that is what you gain through these clinical trials."

Of the nine patients initially enrolled in the same clinical trial, only Nelson and another patient were deemed tumor-free and sent home, notes Dr. Czito.

"There is a lot of room for improvement in cancer treatment," Dr. Czito says. "We will not predict long-term survival in this study but are encouraged by the results so far."

Based on the results of Phase 1, Phase 2 of the trial opened in mid-2009, scheduled to enroll 20 new patients.

Read More "Clinical Trials" Articles

ClinicalTrials.gov Turns 10! / What Are Clinical Trials? / Clinical Trial Results Vary Widely, But Always Advance Research / Volunteering for Clinical Trials Can Help Improve Health Care for Everyone

Fall 2010 Issue: Volume 5 Number 3 Pages 6 - 7