Investigator's Handbook A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI Table of Contents Part A 1 2 3 Part B 4 5 6 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices Part E: Nonresearch or Treatment Referral Protocol Use of Investigational Agents 19. Treatment Referral Center (TRC) 19.1 Purpose 19.2 Method 19.3 Access to the TRC 19. Treatment Referral Center (TRC) 19.1 Purpose The Treatment Referral Center (TRC) is a means for NCI to provide information to community oncologists about therapeutic options for cancer patients with emphasis on referral to Cooperative Group studies or Cancer Centers. The TRC uses the PDQ, http://www.cancer.gov/search/clinical_trials/, and CTEP information systems databases, data supplied by the NCI-designated Comprehensive or Clinical Cancer Centers, and consultations with CTEP physicians to maintain a referral list of the most current active research protocols. For certain high-priority diseases, NCI identifies those stages and amount of prior therapy situations for which it is felt investigational treatments should be available. For each of these patient populations, the TRC will provide a Treatment Referral Center Protocol to the Cancer Centers. If any one of the Cancer Centers feels there are no commercially available treatment options or there is no active clinical trial available for such patient populations, the Cancer Center may choose to use the Treatment Referral Center Protocol as a treatment option. 19.2 Method Information will generally be provided about treatment options using the following algorithm: First priority will be given to suggesting the patient be referred to a major Phase 2 or 3 trial (usually Cooperative Group studies). If the patient is ineligible for or unable or unwilling to enter a Phase 2 or 3 trial, then the physician would be offered the following alternatives: Referral to a participating Cancer Center for evaluation for an investigational protocol. These protocols would offer therapies with potential activity in a specific disease Standard treatment options; e.g., commercially available agents Group C or Special Exception agents, if available Referral to the PDQ database for alternative treatment options, including Phase 1 agents. 19.3 Access to the TRC Physicians at participating Cancer Centers will contact the Pharmaceutical Management Branch to register patients on TRC protocols. Registration procedures and eligibility criteria are provided in the approved TRC protocol. Table of Contents Part A 1 2 3 Part B 4 5 7 Part C 7 8 9 10 11 Part D 12 13 14 15 16 Part E 17 18 19 Appendices

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