Worthwhile Trials

Research participation invigorates radiation oncologists.worthwhile trials

Editor's Note: The April ACR Bulletin featured two radiologists whose practices participate in clinical trials. This month, two radiation oncologists share their motivation to pursue clinical research.

Radiological Associates of Sacramento

Participation in clinical research, although serious and demanding, provides benefits for both the individual radiation oncologist and group practice. That's the view of Christopher U. Jones, MD, FACR, a radiation oncologist specializing in head and neck cancer at Radiological Associates of Sacramento (RAS), a large private practice in central California. Former members of his practice, interested in developing cooperative group radiation oncology research, positioned RAS to become one of the first full-member institutions of the Radiation Therapy Oncology Group in the 1970s. With a team of 15 physicians and five clinical research staff, the radiation oncology center today has 21 trials open and 860 patients in follow-up as a result of its affiliation with RTOG. In addition to championing RAS' participation in RTOG trials, Jones serves as co-principal investigator for RTOG 9408, a phase-III randomized trial of early, localized, favorable-risk prostate cancer that compared radiotherapy (RT) alone and in conjunction with four months of androgen-deprivation therapy, the results of which have been published in the New England Journal of Medicine.

jones headshotThe process of selecting and activating specific trials begins with Jones attending RTOG meetings to become aware of current and upcoming studies. In a subsequent in-house vetting process, the physicians consider which research questions are of interest and which protocols are appropriate for activation at their site. After surveying community medical oncologists and surgeons about their interest in a specific trial, the practice assesses whether it has the resources to obtain follow-up information, perform tests, and comply with pathology requirements of the protocol. "We consider carefully whether we have a sufficient patient population from which to enroll enough participants and whether these patients would be willing to participate in a particular study," says Jones.

“The prestige of maintaining the updated standards required for research participation also assures the hospitals in which we practice of high-quality care.” — Christopher U. Jones, MD, FACR

Benefits of the group's clinical research participation have included the opportunity to keep up-to-date on practice standards for the numerous types of cancer and disease sites, as well as on the appropriate implementation of technological advances for delivering RT, particularly image-guided RT, intensity-modulated RT, and brachytherapy. "Carrying out trials has been especially helpful in determining when and how to use any new technology acquire," adds Jones. "The prestige of maintaining the updated standards required for research participation also assures the hospitals in which we practice high-quality care."

The importance of an informed and motivated clinical research team can't be overstated. "There are too many requirements for physicians to keep up to date without assistance. A good team is educated on governmental and institutional review board issues, proper informed consent issues, patient protections, the purpose of the trials, and how to perform them properly," continues Jones.

Jones advises radiation oncology practices to consider and prepare for the time and financial commitment that clinical research participation requires. This includes significant physician time spent discussing the trials with patients during consultations and answering follow-up questions. "Because we are offering a new type of treatment that may or may not be better than the existing standard of care, patients will have many questions," says Jones.

Regarding his personal motivation to assume RTOG leadership responsibilities, Jones notes, "Making even a small contribution to the advancement of clinical oncological medical care by offering cutting-edge treatment and helping the field move to the next standard of care is satisfying." Attending RTOG meetings helps Jones keep current in his specialty of head and neck cancer — a field in which the advanced scientific questions outnumber the patients available for study enrollment. "It's exhilarating to talk with colleagues specializing in different areas and to hear their thought processes about cancer management," he adds. "It keeps the field fresh and fun for me."

Christiana Care Health System

Adam Raben, MD, is a member of a private radiation oncology practice affiliated with the Christiana Care Health System in Newark, Del. He credits his practice's leadership roles in cooperative group clinical research, including RTOG, with laying the groundwork for more cohesive interaction among the disciplines at Christiana's Helen F. Graham Cancer Center. "Over the last decade, our cancer center has moved from performing assembly line oncology to a multidisciplinary approach that fully integrates nursing staff into the process," elaborates Raben.

The center has witnessed a growing commitment to putting patients on clinical and cancer-control trials since it became part of the Christiana community clinical oncology program (CCOP). "We are currently the second highest-accruing CCOP member in the United States and the highest-accruing single institution," reports Raben.

adam raben and stilesAdam Raben, MD, and Karen Sites, BSN, RN, OCN, conduct clinical research at Christiana Care Health System in Newark, Del.A driving force behind this accomplishment is a growing belief by physicians nationally that putting patients on clinical trials is both important and worth the effort, evidenced by its prominence in the cancer center's mission. A second force is the nursing support available through a network of multidisciplinary clinics, each including a nurse navigator, clinical research nurse, clinical nurse, speech and swallowing expert, psychologist, and nutritionist. This results in streamlined treatment-plan development and up-front screening of patients for trial eligibility. "Without the enthusiasm displayed by our highly qualified and motivated nurses, who believe in the same mission as the physicians, we wouldn't be able to maintain our high level of patient enrollment," says Raben. A third factor is the practice's clinical expertise in treating many different malignancies (e.g., sarcoma, breast, head and neck, pancreas, lung, and central nervous system), which increases its ability to enroll patients into a wide variety of RTOG trials. As a result, Christiana currently is participating in 12 active RTOG trials.

“It comes down to whether you’re advancing cancer management or not, and we wanted to be part of the RTOG research mission that is committed to enhancing and improving patient outcomes.” — Adam Raben, MD

Karen Sites, BSN, RN, OCN, nurse coordinator and RTOG research associate at Christiana, believes the center's enrollment success is related to the research department being embedded in the radiation department office space. "We are accessible to inform the physicians, nurses, and dosimeter therapists of potential research patients as well as to complete enrollment and follow patients throughout treatment," notes Sites. "Research is a high priority, and the buy-in of everyone involved is important." Sites also emphasized the open communication among the research staff and the physicians and their staff that allows them to freely discuss the circumstances involved in getting a patient on a study.

Raben's desire to ensure that treatment management is cost effective led him to participate in clinical research. Another evolving motivation is RTOG's growing recognition of the significant contribution of CCOPs. "Over the last year and a half, we have been named as authors of multiple abstracts and future manuscripts due to our level of enrollment," states Raben. "It's also gratifying to have the opportunity to offer patients new clinical treatments provided by highly experienced physicians within their own community." Additionally, Raben finds intellectual stimulation in interacting with RTOG colleagues across the country regarding the future direction of research, which serves as a remedy for potential burnout — a problem documented at rates approaching 95 percent among oncologists.

Raben expresses concern about the lag time between the publishing of a landmark radiation oncology trial's results and their adoption into clinical practice. "Governmental and private insurers may be unaware that physicians are still using or offering patients treatment modalities and regimens that have been proven ineffective. Our practice is committed to quickly carrying out new standards of care," Raben says. "It comes down to whether you're advancing cancer management or not, and we wanted to be part of the RTOG research mission that is committed to enhancing and improving patient outcomes."

By Julie Catagnus, MSW, ELS

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