The Radiation Therapy Oncology Group (RTOG) is a national clinical cooperative group funded by the National Cancer Institute (NCI) since 1968 to increase the survival and improve the quality of life of patients diagnosed with cancer. The primary areas of research for RTOG investigators are: brain tumors, head and neck cancer, lung cancer, cancers of the gastrointestinal system (esophagus, rectum, anal canal and stomach), genitourinary tract cancers (bladder and prostate), sarcomas, gynecologic cancer (cervix) and breast cancer. The Group consists of both clinical and laboratory investigators from over 260 institutions across the United States and Canada and includes in its membership nearly 90% of all NCI-designated comprehensive and clinical cancer centers. The Group Headquarters and Statistical Unit are located in the Philadelphia offices of the American College of Radiology. The Group Chair is Walter J. Curran, Jr., M.D. of Thomas Jefferson University, Philadelphia.

During its 35-year history RTOG has conducted many studies that have improved the survival and quality of life of cancer patients. The results of the eight RTOG studies listed below are some of RTOG’s most recent accomplishments. Each of these studies has defined new national standards of care for cancer patients and each has led to the development of a new RTOG protocol that seeks to further improve upon these results.

Cancer of the Cervix – RTOG Study 9001 demonstrated that combining chemotherapy (cisplatin) with pelvic radiation improves the survival rate for women with locally advanced cervix cancer. A NCI Clinic Alert was issued in 1999 and the initial results were published in the New England Journal of Medicine. The 5-year survival rate for women enrolled on the cisplatin plus radiation arm is 73 percent, compared to 58 percent for women enrolled on the radiation-alone arm.

Lung Cancer – The results of a landmark three-arm trial, RTOG 9410, for favorable-performance-status patients with inoperable non-small-cell lung cancer reported the superiority of combined chemotherapy and radiotherapy given at the same time over chemotherapy followed by radiotherapy.

Head and Neck Cancer – RTOG completed the largest Phase III trial for patients with locally advanced head-and-neck squamous-cell carcinoma, RTOG 9003. This four-arm trial enrolled 1,113 patients and demonstrated the superiority of concomitant boost radiotherapy (standard radiation therapy with an extra “boost” to a specific tumor area) and hyperfractionated radiotherapy (radiation give twice a day) over standard radiotherapy for this group of patients.

The RTOG-led intergroup three-arm study for patients with advanced resectable larynx cancer, RTOG 9111, determined that laryngectomy-free survival was significantly better for patients on the combined chemotherapy/radiation therapy arm than for patients treated with radiotherapy alone. Time to laryngectomy (removal of the larynx) was also significantly better for patients who received combined chemotherapy /radiotherapy compared to the patients who received the chemotherapy or radiation therapy alone. There was no difference in the number of patients who were alive at two years with their larynx intact when combined therapy was compared to chemotherapy or to radiation alone.

Prostate Cancer – Through three large Phase III trials, RTOG investigators have determined that overall and disease-free survival rates are significantly improved for men with high-grade prostate cancer (Gleason Score 8-10) who receive long term hormone therapy and radiotherapy. For patients with locally advanced prostate cancer receiving hormone therapy prior to radiotherapy results in improved survival.

CNS Lymphoma - RTOG conducted a phase II trial, RTOG 9310, of high-dose chemotherapy (methotrexate, vincristine and procarbazine) given in five cycles over a 10-week period prior to radiotherapy for patients with non-AIDS related primary central nervous system (CNS) lymphoma. The median survival time for the 98 analyzable patients was 30.4 months. The median survival for a previous RTOG study (8315) of the same patient population treated with radiotherapy alone was 11.6 months.

A cooperative group is a research project of the National Cancer Institute (NCI) that brings together many investigators from hospitals and academic research centers throughout the United States. There are currently nine cooperative groups funded by the NCI to study adult cancers. RTOG is one of these groups.

The goal of each of the cooperative groups is to bring the combined talents and resources of many institutions together to improve the treatment options for patients with cancer. The cooperative group members elect officers, form research committees, design research studies, enroll patients on these studies, analyze the research data, and publish the results in peer-reviewed national publications. Each group designates a Headquarters for data management, statistical analysis, and administrative review procedures. Each cooperative group continually monitors its members and their patient records to insure that the research studies are conducted safely and that the research data is accurate.

A clinical trial is a research study that is designed to answer a question about cancer treatment. Preclinical or laboratory studies are performed using animals, human tissue (biopsies), or computer simulations to study the potential effect of experimental drugs, radiation delivery systems or treatment schedules.

Phase I trials are the first step in testing a new treatment on humans. In these studies researchers look for the best way to deliver a new treatment (for example, How much drug or radiation should be given and what is the best way to deliver the new treatment?). Researchers also assess any side effects that result from this new treatment. Since this is the first stage in gathering information about the new treatment only a small number of patients, who would not be helped by other known treatments, are entered on a Phase I study.

Phase II trials focus on learning whether the new treatment has an anticancer effect (for example, Does it shrink or destroy a tumor?). Phase II studies usually involve a small number of patients.

Phase III trials compare two or more treatments to determine which treatment is the best for a particular type of cancer (for example, Which treatment has the best survival rate or local control rate? Which treatment has the fewest side effects?). Phase III trials usually compare the standard treatment to one or more treatments that have shown promise in Phase I and II testing. These trials may involve hundreds or thousands of patients from around the country.

Randomized trials are studies testing two or more treatments. Since it is not known which of the treatments is best, patients are randomly assigned, often by a central office (for example, RTOG Headquarters), to receive a specific treatment. Most often a computer program does this assignment, and the patient has an equal chance of receiving any of the proposed treatments. Neither the patient nor the doctor will know ahead of time which treatment will be assigned. Sometimes drug studies, which can use a placebo (an inactive agent), are “double-blinded,” and neither the doctor or the patient know which treatment is assigned until the study is completed. Randomly assigning treatment arms helps the researchers avoid bias or having the study’s results affected by human choices or preferences. All Phase III trials are randomized, and so are some Phase II trials.

Clinical trials contribute to the knowledge and progress against cancer. If a new treatment proves effective in study, it may become a new standard treatment that can help many patients. Clinical trials may also answer important scientific questions and suggest future research directions. Because of progress made through clinical trials, many people treated for cancer are now living longer and with a better quality of life.

Patients who enter clinical trials receive high-quality cancer care by experts in their field. All participants receive either state-of-the-art treatment that may not be otherwise available, or they receive the best standard treatment for their disease. Since it is not known if the new treatment is as good as, or better than the standard treatment, no one can predict if a patient will personally benefit from their participation. It is hoped that information gained from the study will benefit other patients with that disease.

The treatment costs for most studies are generally considered part of normal cancer care and are billed to the participant’s insurance carrier; however, expenses not covered by insurance or Medicare may be billed to the participant. The study organizers may pay for certain experimental drugs or procedures. Participants should discuss these issues with their doctor.

Taking part in a research study is voluntary. Patients may choose not to take part or may leave a study at any time. If a patient wishes to stop participating in the study, the patient should first discuss this with his/her doctor. In order to provide important information that may add to the analysis of the study, the doctor may ask permission to submit follow-up data as it relates to the study. Patients may accept or refuse this request. Leaving the study will not result in any penalty or loss of benefits.

If the study has more than one treatment option patients will most likely be randomly assigned a treatment by a computer at RTOG Headquarters. Neither the participant nor the doctor can choose which treatment is assigned.

No, your continued participation in the study is very important. Each and every patient’s continued participation helps to assure that the results of the study can be accurately analyzed. First, you need to inform the physician who enrolled you into the study of your plans. This physician’s staff can make arrangements with your new doctor to supply follow-up information related to the study. This may require that you sign a form authorizing the physicians to have access to study specific data. Second, you should also provide your study doctor with information that will allow him/her to contact you directly, if necessary. There may be important information about the study that he/she might want to share with you.

It is strongly advised that you continue to be followed; however if this is not practical for you, please permit the study doctor or his/her staff to periodically contact you on behalf of the study. Each person enrolled in a clinical trial is critical to the research and your information is uniquely important. Periodically, try to update your contact information with the study investigator so this process can continue.