NEWS

Community Clinical Oncology Program Celebrates 20 Years of Trials and a Few Tribulations

Gwen Moulton

Twenty years after the creation of the National Cancer Institute’s Community Clinical Oncology Program (CCOP), the underlying collegiality and collaboration of people networked across the country in 61 community programs known as CCOPs and 14 national research bases, have not waned. The program was established in 1983 to provide a mechanism for community physicians at large to be involved in cancer clinical trials, to bring the benefits of clinical research to patients in their own communities.

"The CCOP legacy is that they’ve contributed to the cooperative groups’ ability to start trials, complete trials, and affect the way physicians care for patients and individuals at risk for cancer," said Leslie Ford, M.D., associate director for clinical research in NCI’s Division of Cancer Prevention.

Administrators and investigators celebrated the 20th anniversary of CCOP last month at the annual meeting of the National Surgical Adjuvant Breast and Bowel Project, an NCI-sponsored clinical trials cooperative group, and recalled the program’s trials and tribulations over the years.

Predecessors and Controversies

The 1971 National Cancer Act and 1974 amendments aimed to decrease the gap in care among communities and academic institutions by mandating programs to speed the application of state-of-the-art cancer care in non-academic settings.

Before CCOP were the Community Hospital Oncology Program and Community Oncology Program, which were based on the hypothesis that the most effective way to transfer successful cancer technology to community physicians would be to develop patient management guidelines. The Cooperative Group Outreach Program was established for community hospitals to participate in cooperative group cancer treatment clinical trials.

Then NCI director Vincent DeVita, M.D., announced in 1981 at the annual meeting of the Association of Community Cancer Centers the vision that would become CCOP: a large number of free-standing community cancer centers linked to the cooperative groups and comprehensive cancer centers to conduct clinical research on the largest scale ever as a means of disseminating the standards of care.

The CCOP vision was controversial from the beginning. When the concept went before the Board of Scientific Advisers in May 1982, critics expressed concern about community physicians’ ability to provide both high-quality clinical research and a level of care comparable to that at the cancer centers.

"Twenty years ago when this program started, many people did not believe that community oncologists could participate in cancer clinical trials," current NCI CCOP director Lori Minasian, M.D., observed. "Early on in the program, we showed that not only could they participate but they could do so with high-quality data."



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Dr. Lori Minasian

 
Robert W. Frelick, M.D., an oncologist in Delaware who helped the NCI launch the program, recalled disputes that in some cases remain actively debated. Among them was the issue of separate grant payments to the individual CCOP centers. The NCI-supported clinical cooperative groups and cancer centers, which serve as the research bases for CCOPs, generally wanted to control funding, he said. But separating it was crucial to allow the CCOPs to develop a sense of responsibility to the research and to build an infrastructure to support community physicians’ protocol activities. The overall role of the research bases, on the other hand, was to design protocols in treatment, prevention, and early detection; manage and analyze all data collected; and monitor data quality and subject accrual.

How well local CCOP institutional review boards would administer informed consent was another concern. A revised system ultimately improved protocol surveillance for human research risk at both the CCOPs and cooperative groups, he said. A different NCI requirement, that CCOP members keep a log of all patients who might be eligible for an approved research protocol, was disliked by community physicians and eventually eliminated, he said, but the effort provided good data as to why people did not go on treatment trials.

A Stronger Research Network

In 1983, more than 200 applications were submitted for NCI’s first call for applications, and 62 CCOPs were funded. The second request for applications in 1987 required that oncologists enroll patients to cancer control and prevention clinical trials. Charles Coltman Jr., M.D., chairman of the Southwest Oncology Group (SWOG), which conducted the Prostate Cancer Prevention Trial (PCPT) and the ongoing Selenium and Vitamin E Cancer Prevention Trial (SELECT), noted the significance the CCOPs would later have in accruing normal healthy men for prevention trials.

PCPT, started in 1993, was the "first cancer prevention trial that showcased how well CCOPs conducted themselves in a large trial," with an accrual rate that was "astonishingly high" relative to other groups, he said. It tested the difference in prostate cancer incidence between a group of participants given finasteride and a group given a placebo for 7 years. Results from PCPT were released nearly a year earlier than expected in 2003. (See News, July 16, 2003, Vol. 95, No. 14, p. 1030.)

SELECT, a prostate cancer prevention study that began in 2001 while PCPT was still ongoing, has reached 82% of its accrual goal of 32,400 participants just 27 months into a projected 5-year effort, he noted. CCOPs have accrued 22% of the total number of patients enrolled so far.

Norman Wolmark, M.D., chairman of the NSABP, which in 1992 conducted the first major chemoprevention trial, the Breast Cancer Prevention Trial, recalled the overall skeptism toward cancer prevention research in the 1970s and 1980s. Yet, the first U.S. prevention trials succeeded whereas European trials did not, he said, "because there was a national system of support that underwrote the effort." He added, "It is because of the people in this room (at the CCOP anniversary celebration), the success of the American system was due to protagonists who devoted their entire lives to the quest of prevention."

Today’s CCOP

With a 2003 fiscal year budget of almost $100 million (compared with about $8 million in 1983), the CCOP program now includes more than 4,000 community physicians in private practices and 403 hospitals. NCI has funded different CCOPs over the years. Of the current group, 27 have received continuous funding since the beginning (see box). Since 1993, there have been 11 minority-based CCOPs, which are defined as having at least 40% of newly diagnosed cancer patients from minority populations in their communities.

From the start, CCOP administrators have experienced the complexities of increased regulatory oversight with the greater efficiency of electronic submissions, said Marge Good, administrative director of the Wichita CCOP. They have gone from typewriters to laptops; telephone recruitment to online registration; data managers to credentialed information specialists; inpatient treatment to outpatient treatment; one-pound grant applications to 10-pound grant applications; a few specialists to many specialists and primary care physicians; and from so few available studies they could fit on a single card to so many they fill a booklet.

Howard A. Zaren, M.D., described the experience of the newest minority-based CCOP, Cook County Hospital, in Chicago, where he is the principal investigator and chairman of the Department of Surgery, and a professor of surgery at Rush Medical College. More than half of the cancer cases in Illinois are in Cook County, yet there was no organized cancer care when he arrived in 1999.

Of Cook County Hospital’s 1,200 cancer patients in 2002, 57% were African American, 36% white/Hispanic, and about 6% Asian, he said. They often had no child care, no transportation, and unsympathetic employers; substantial co-morbid disease; risk factors of alcohol and smoking; and little access to screening. The most common cancers were breast, prostate, lung, head and neck, and colorectal at all stages of disease.

Becoming a minority-based CCOP put organization into the system, he said, and put into place an infrastructure and support to expand clinical research, including a database and the personnel to track patients and help the non-English speakers understand the system.

Of their 215 patients on NCI breast cancer clinical trials, 10% are on prevention trials and the rest are on treatment trials. The minority-based CCOP is ready to take this template to the next step and deal with other common cancers, Zaren said, to make sure everyone is treated the same and has the advantages of state-of-the-art treatment and prevention.

Today, CCOPs accrue one-third of patients who participate in NCI-sponsored cancer treatment trials. Since the program began, CCOP participation has resulted in more than 98,000 patients on treatment trials and more than 77,000 people at risk for cancer on prevention trials. More than 90 cancer prevention and control protocols were open and actively accruing across all of the research bases in 2003.

Although success is clear, Frelick suggested, there is still room for improvement. He said that there needs to be a better partnership between the community oncologists in general and the NCI leadership, much of which, Frelick contended, still does not completely understand how to best work with community oncologists and their valuable innovations.

Into the Future

An outside evaluation of CCOP in 1992 focused on aspects of the program that were initially anchored in the cancer treatment model. Conducted by Arnold Kaluzny, Ph.D., of the University of North Carolina at Chapel Hill, and Dr. Richard Warnecke, Ph.D., of the University of Illinois, Chicago, the study found key attributes of treatment-oriented cooperative groups and community programs that would lead to the successful implementation of a community-focused, prevention and control trials network. Kaluzny described a major factor contributing to this as the "enthusiasm and commitment of the local CCOP and research base personnel. That involved not only the physicians, but the nurses and data managers at both these organizations."

Follow-up evaluations began in 2003 to understand the extent to which cancer control and prevention research and the role of CCOPs have been institutionalized into ongoing activities of the research bases.

"CCOP provides an infrastructure for the future," Kaluzny said. "As the science of preventive oncology moves forward, it will require the CCOP infrastructure. If we didn’t have it, we would have to build it given the requirements of doing prevention trials."

Minasian echoed that sentiment. "As we look to the next 20 years, the need for participation and commitment to clinical trials is more important than ever.

"The clinical trials that evaluate agents for their ability to prevent cancer require long time frames and participants without active disease," she said. "The community physicians are at the forefront of outreach to primary care physicians and participants at risk for developing cancer."


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