RTOG FAQ for Researcher

FAQ for Researchers

What is RTOG?

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 focus 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. Some recent achievements are listed below:

Cancer of the Cervix – RTOG Study 9001 demonstrated that combining chemotherapy 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 concurrent chemo-RT (chemotherapy and radiotherapy starting on day 1) vs. sequential chemo-RT (chemotherapy followed by radiotherapy on day 50). The 2-year median survival is 17.1 months for patients treated with concurrent chemo-RT compared to 14.6 months for patients treated with sequential chemo-RT.

Head and Neck Cancer – RTOG completed the largest Phase III trial, RTOG 9003, for patients with locally advanced head-and-neck squamous-cell carcinoma. This four-arm trial enrolled 1,113 patients and demonstrated the superiority of concomitant boost radiotherapy and hyperfractionated radiotherapy over standard conventional 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 concurrent chemo-RT arm than for patients treated with radiotherapy alone. Time to laryngectomy was also significantly better for patients who received concurrent chemo-RT compared to the patients who received the induction chemotherapy or radiation therapy alone. There was no difference in the two-year laryngectomy-free survival when concurrent chemo-RT was compared to induction 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 suppression and radiotherapy, whereas for locally advanced patients with Gleason Score 2-6, neoadjuvant hormone suppression is responsible for improved survival.

CNS Lymphoma - RTOG conducted a phase II trial, RTOG 9310, of high-dose 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.

What are the requirements to become an RTOG member?

The Requirements for Institutional Membership can be found in Appendix III of the RTOG Procedure Manual. The Criteria for Maintaining RTOG Membership can be found in Appendix IV of the RTOG Procedure Manual.

What are the RTOG membership categories?

RTOG has four membership categories: Full, Provisional, Affiliate, and CCOP. Full Members are required to accrue 50 cases on RTOG studies each year with at least 25 of these cases originating with the Full Member institution. Full Members must also maintain satisfactory data quality scores as defined in Appendix IV of the RTOG Procedure Manual. Affiliate Members collaborate with a Full Member institution which is responsible for the data quality of its affiliate members. Affiliate Members must place 5 cases on protocol each year and maintain satisfactory data quality scores as defined in Appendix IV of the RTOG Procedure Manual. Provisional Full Membership is granted to an Affiliate Member that has placed 25 cases on study in the last year and has petitioned the Membership Evaluation Committee to become a Full Member. In addition to the 25 cases, the institution must have a satisfactory data quality score and undergo a site visit by a Membership Evaluation team. A Community Clinical Oncology Program (CCOP) Member is funded as such by the NCI and has included RTOG as a research base.

How can I join RTOG?

Researchers interested in becoming an RTOG member must first submit a copy of the RTOG preliminary application to RTOG Headquarters. Instructions and a copy of the preliminary and complete applications are available on the RTOG Web site.

The preliminary application is reviewed by the RTOG Headquarters administrative staff and the RTOG Membership Evaluation Committee. ALL performance sites must be listed. If patients will be treated at sites other than the applicant institution, a description of the corporate structure, its relationship to the applicant institution and the IRB assurance that covers these sites must be submitted. RTOG will then determine the membership type for the applicant institution. Once that determination is made the institution can submit an application for membership which is available at our Web site.

RTOG Application For Membership – This is the second step in the RTOG membership application process. All applications for membership are carefully reviewed by administrative staff, a physicist and the Membership Evaluation Committee. If several sites comprise an institution, an application form must be completed for each site. Affiliate applications, will be asked to indicate the desired activation date on the application form. Please keep in mind that affiliates are required to place five treatment cases on study in the first year of membership and in every calendar year thereafter. For this reason, we recommend you activate your membership within six months of notification of approval.

The non-refundable fee for submission of an Affiliate Membership Application is $3,000 plus $1,000 for each additional performance site, if the site is independent and provides treatment. Checks should be made payable to the American College of Radiology/RTOG.

Requirements for Membership – RTOG has specific requirements for personnel, equipment, record keeping and human subjects’ protection. These requirements can be found in the RTOG Procedure Manual, Appendix III.

Other Requirements – It is recommended that your Research Associate attend an RTOG orientation session. For more information about these sessions, please call Joanne Ley at RTOG Headquarters (215) 574-3201. In addition, all physicians and staff at the applying institution are required to complete the National Institute of Health Human Subjects Research Course. The course is available on line at http://cme.nci.nih.gov

Communications with Headquarters – All correspondence from RTOG to the Affiliate will be sent to the registered Principal Investigator and/or Research Associate. It is their responsibility to distribute this information to participating sites and investigators.