Clinical research is often conducted in trials that are run by organizations that include patients from a variety of institutions from across the United States, Canada, and elsewhere. The reason for this is that single institutions may not see enough patients to perform a clinical trial in a reasonable period of time (5 to 10 years or less). The most convincing evidence often comes from trials in which patients are randomly allocated to two or more treatment arms.
The University of Florida participates in multi-institutional trials that are run by the Pediatric Oncology Group, Radiation Therapy Oncology Group, and Eastern Cooperative Oncology Group. Patients who may be eligible to be included in a study are informed of this by their attending physician. The study is explained in detail by their doctor, and if they wish to participate, they sign an “informed consent” form detailing the study procedure and expected results. The patients receive a copy of the consent form, and a copy also is placed in their medical record.
The decision whether or not to participate in a trial is solely at the discretion of the patient. If patients decide not to participate in a trial, it in no way adversely affects the quality of their medical care.
Multi-institutional clinical trials are a very important way for the medical community to evaluate the effectiveness of various kinds of treatment. They offer a way for physicians and patients to contribute to our search for better ways to treat cancer.
Radiation Therapy Oncology Group (RTOG)
For more general information about the RTOG, you can visit their Web site.
The Radiation Therapy Oncology Group was organized in 1968 to conduct radiation therapy research and cooperative clinical cancer investigations. Funding from the National Cancer Institute was first obtained in 1971 and has continued ever since. Since its beginning, the RTOG has activated more than 271 treatment protocols and has included more than 56,000 patients in its cooperative group studies.
Objectives of the RTOG include the following:
- improvement of survival rates for major types of cancer evaluation of new treatment methods
- decrease in long-term complications of radiotherapy
- study of the best ways to combine radiotherapy with surgery and drug therapy
- prevention of second cancers in patients cured of cancer
The University of Florida became an Affiliate Member of the RTOG in November 1994.
RTOG protocols are designed by leading radiation oncologists from all over the country; each study is intended to answer specific questions about treatment of cancer. Before patients can be accrued to an RTOG study at the University of Florida, the RTOG protocol must be submitted to the University of Florida Institutional Review Board, where stringent standards of patient care and accountability must be demonstrated. Once IRB approval has been obtained, accrual of patients can begin.
Radiation Oncology faculty members may offer this experimental treatment to patients who are eligible. Other treatment options are also explained and discussed.
Children’s Oncology Group (COG)
The University of Florida is a member of COG and more information about this group can be found at their Web site.
Over the last half of the 20th century, progress in childhood cancer diagnosis and treatment has transformed a once uniformly fatal disease into a group of malignancies that are now curable in most children. This triumph occurred through the efforts of clinical investigators, laboratory scientists and the national cooperative clinical trials groups. With this success has come the realization that the goal of curing all children with cancer is achievable, with a heightened recognition of the need to reduce long-term treatment effects and improve quality of life.
With past successes and new hopes, the major pediatric clinical trials groups based in North America-the Children’s Cancer Group(CCG), the Pediatric Oncology Group (POG), the Intergroup Rhabdomyosarcoma Study Group (IRSG) and the National Wilms’ Tumor Study Group (NWTSG)-have agreed to formally combine their efforts to accelerate the search for a cure and potential prevention of cancer in children and adolescents. The COG mission statement is:
“To cure and prevent childhood and adolescent cancer
through scientific discovery and compassionate care.”
Cancer clinical trials are proven to offer children the best chance of survival. Cancer clinical trials are designed to study the effectiveness of particular anti-cancer strategies, such as promising new drug combinations, by carefully monitoring and anlyzing how patients respond to treatments. For children with cancer, participation in clinical trials significantly increases survival rates.
Clinical trials are essential in the fight against cancer. Most of the major advances in the fight against cancer have been made through the cooperative group clinical trial system.
- COG typically has 100 studies open to patients
- COG enrolls around 5,000 patients each year on its treatment studies
- An estimated 35,000 childhood cancer survivors are in active follow-up by COG
Eastern Cooperative Oncology Group (ECOG)
To find out more general information about ECOG, you can visit their Web site.
The Eastern Cooperative Oncology Group (ECOG) was established in 1955 as one of the first cooperative groups launched to perform multicenter cancer clinical trials. Funded primarily by the National Cancer Institute (NCI), ECOG has evolved from a five-member consortium of institutions on the East Coast to one of the largest clinical cancer research organizations in the U.S. with more than 5,000 physicians, nurses, pharmacists, statisticians, and clinical research associates (CRAs) from the U.S., Canada, and South Africa. Institutional members include universities, medical centers, Community Clinical Oncology Programs, and Cooperative Group Outreach Programs. These institutions work toward the common goal of controlling, effectively treating, and ultimately curing cancer. Research results are provided to the world-wide medical community through scientific publications and professional meetings.
Currently, ECOG has more than 80 active clinical trials in all types of adult malignancies. Annual accrual is 6,000 patients with more than 20,000 patients in follow-up.
Examples of ECOG clinical trials that have changed or improved cancer treatment methods include the following:
- Studies that demonstrate that taking tamoxifen for 5 years rather than only 1 year after breast surgery is more effective in preventing the recurrence of breast cancer.
- Studies that indicate malignant melanoma of the skin can be treated effectively with less deforming surgery and that interferon alpha delays the time to recurrence after surgery.
- A study that establishes an effective treatment program involving chemotherapy and radiation therapy for early lung cancer.
At the University of Florida, the primary responsibility for ECOG registration and follow-up is located in the Medical Oncology Division. However, physicians in the Radiation Oncology Department play an active role in protocols involving radiation therapy.