The Promise of Clinical Trials in
Preventing and Treating Cancer
Kate Soons was only thirty six when she learned she was at risk of developing breast cancer. In 1998, her maternal grandmother was diagnosed with the disease, and then in the years following, two maternal aunts also developed breast cancer. Armed with a desire to turn worry into action, Soons visited the Breast Care Center at Fletcher Allen for a consultation and learned about and joined a Vermont Cancer Center prevention study, called "Statins and Breast Cancer Biomarkers," for women at increased risk of developing the disease.
A surgical intensive care nurse and volunteer assistant chief of Colchester Rescue, Soons has dedicated her life to helping others. Enrolling in the study, she says, allowed her to support her grandmother and aunts while helping scientists search for ways to prevent breast cancer.
Soons is not alone. Each year, more than 3,000 people participate in clinical trials at the VCC. For Grand Isle resident Arthur Goodrich, 72, the decision to enter a study was prompted by a diagnosis. The self-proprietor of an auto repair shop and former smoker of 46 years, Goodrich learned he had lung cancer following weeks of a persistent cold he simply couldn't shake. Goodrich visited his family physician Dennis Plante, M.D., who referred him to Fletcher Allen, where he was treated in the Lung Multidisciplinary Clinic.
A key member of Goodrich's care team was Bruce Leavitt, M.D., cardiothoracic surgeon and cancer researcher. Leavitt and Goodrich's other physicians believed he was a strong candidate for an innovative lung cancer surgical study that is determining whether a wedge resection, which removes a small section of the lung, is as effective as a lobectomy, which removes the entire lobe of the lung.
When Leavitt offered the opportunity to participate in the study, Goodrich was enthusiastic. "I can't believe a person could say no to something like that," says Goodrich. Leavitt believes the possibility of the study having an impact on patients' quality of life is significant. Lung-conserving surgery has the potential to do for lung cancer patients' quality of life what breast-conserving lumpectomy has done for breast cancer patients.
Taking research out of the laboratory and bringing it to life as a new, innovative treatment for patients is the result of efforts by researchers and people like Soons and Goodrich. The purpose of a clinical trial is to determine whether a new prevention, screening diagnostic, or treatment option is safe and effective, and if it is better than current therapies. Most clinical trials are randomized, which prevents bias in research by making certain that participants have the same chance of being assigned to an experimental group or control group. Such studies are "double-blinded," so neither the physician nor the patient knows who is assigned to which group.
Breast cancer specialist Marie Wood, M.D., leads the statins study and believes such work is vital to moving research forward. "Clinical trials are exceedingly important," she says. "The reason patients have standard-of-care options today is because people before them participated in clinical trials."
One of the most intriguing things learned at this year's American Society of Clinical Oncology meeting, she says, is that, according to a recent European study, people who participated in trials appear to live longer. "A study like this shows us that participating in clinical trials really has to be considered state-of-the-art care," she says.
At the VCC, a variety of safety mechanisms protect participants of clinical trials. A Scientific Review Committee and Institutional Review Board (IRB) review all studies, and each oncology specialty group and a Data Safety and Monitoring Board supervise studies to ensure patient safety.
A major misconception of clinical studies is that patients receive placebos for treatment, when, in fact, they always receive the standard of care treatment plus either the drug being tested or a sugar pill. Placebos are never used in place of standard treatment.
Chris Holmes, M.D., Ph.D., a hematologist-oncologist at Fletcher Allen, is a cancer researcher and a member of the IRB. "The only way that we can know if what we do in the laboratory will actually be of benefit to our patients is to have patients participate in clinical trials," she says. "One of the greatest success stories of trials leading to effective therapies involves childhood cancer." Participation of children in clinical studies, in fact, is estimated to be as much as ten times that of adults. As much as 65 percent of pediatric patients enroll in clinical trials today, and survival rates for childhood cancer are now nearly 80 percent, according to the National Cancer Institute-sponsored Children's Oncology Group.
One year out from his surgery and treatment, Goodrich is cancer-free and credits his good health to the state-of-the art care he received as part of the clinical trial. Participating in the clinical study, he says, was "a no-brainer." "If I can help somebody else by doing it, I am more than willing to do that," he says.
Soons echoes Goodrich in her experience on the VCC study. "I would definitely participate in any study that I was eligible for. If everyone who was eligible to participate did, think of how much data could be collected."
