From left are: Mike Phalen, Microvasive marketing director; Dr. James B. Edwards; Steve Moreci, Microvasive, VP; Dr. Peter Cotton; Mike Banik, Microvasive New Product Development, Dr. Patrick Mauldin; Dr. Carol Redmond and Dr. Ray Greenberg.

Representatives from Boston Scientific Corporation’s Microvasive Endoscopy Division met with MUSC officials Sept. 12 to launch a major international esophageal cancer study to be coordinated by MUSC’s Clinical Trials Initiative. Microvasive is providing funding for the trial.

Called the SORTIE (Stent or Radiation Therapy Intervention for Esophageal Cancer Dysphagia) Trial, it is a sophisticated prospective comparison of two methods for treating patients with advanced esophageal cancer.

Cancer of the esophagus, or the food pipe, is a particular problem among lower income residents in South Carolina. Unfortunately, by the time these cancers are diagnosed, most of them are incurable.

MUSC’s Digestive Disease Center provides an ideal platform for improving the situation because of its multispecialty structure and emphasis on clinically relevant research. The center’s gastroenterologists, surgeons and oncologists have developed a multidisciplinary and multifaceted program to attack this problem, looking particularly at identifying high risk patients and populations, and the potential for screening them.

“We all want to treat patients better,” said trial director Dr. Peter Cotton. “The trick is to determine what is better. Our emphasis at the Digestive Disease Center is to be patient-friendly, to tailor our methods of investigation and treatment to convenience, efficiency and enhanced quality of life,” Cotton said, “not just the traditional endpoints such as longevity and risk.”

Cotton explained that once it has been determined that the patient cannot be cured by surgery (or other therapies), doctors concentrate on relieving the worst symptoms. This is called palliation. Difficulty swallowing is usually the major problem.

Multiple methods are used to improve swallowing. These include radiation therapy, and various ways of treating the cancer through the mouth with endoscopy. Endoscopes are flexible telescopes through which doctors can deliver treatments which can open up the esophagus. Laser therapy has been widely used. More recently “expandable stents” have been developed. These are wire mesh tubes which expand within the esophagus, to keep the esophagus open.

“It’s not clear which of these palliative treatments are best,” Cotton said. “Although expandable metal stents and palliative radiation therapy are the most commonly used around the world, no one has compared their results in a rigorous scientific manner.”

This study, chosen by MUSC’s newly developed Clinical Trials Initiative, is the initiative’s first major clinical trial. The Clinical Trials Initiative is led by Drs. Carol K. Redmond and Patrick D. Mauldin, who are also co-principal investigators of the SORTIE Trial.

Because it is necessary to study large numbers of patients to make sure that the study answers are correct, other centers in addition to MUSC must be involved. Leaders of this study have recruited 13 other centers, 10 from major academic centers in the United States, two from England and one from Norway.

Representatives of these centers, including gastroenterologists, surgeons, radiation oncologists, biostatisticians and health economists, met in Charleston during the weekend of Sept. 12 to get the trial started. Representatives of the study team and the sponsor met with MUSC president Dr. James B. Edwards and vice president for academic affairs and provost Dr. Ray Greenberg at the beginning of the planning meeting.

“It is to Boston Scientific’s and Microvasive’s credit that they provide support for the study,” Cotton said. “They manufacture the stents which will be used in the trial, yet they have no idea if their product will be found to be better than other treatments.”

The company is convinced, however, that this type of study—focusing on patients’ quality of life and cost-benefit issues—will be increasingly important during the next few years. Microvasive marketing director Mike Phalen said that data from this type of trial will help the company know where to channel its research and development efforts.