Clinical Trial Advancement and Development for Sarcomas

ABSTRACT Suitability. Dr. Harris is well-suited for the Early Career Cancer Clinical Investigator Award (ECIA). His clinical trial interests and career plans focus on optimizing outcomes with radiation therapy for sarcomas. Planned Activities. Clinical Trial Training. Dr. Harris will enroll in the SWOG Early Career Training Course. This course involves one-on-one mentorship, a course, and an in-person workshop. Dr. Harris will also enroll in Clinical Trials Project Management, a project management course at the University of California Irvine (UCI). Mentorship Plan. Dr. Harris has identified Dr. Warren Chow, a leader in sarcoma clinical trials at UCI, and Dr. Lara Davis, head of the SWOG Sarcoma Working Group and co-chair of S2505. Dr. Harris will meet regularly and work with both mentors throughout the ECIA period. Cancer Committee Involvement. At the UCI Cancer Center level, Dr. Harris will continue his role on the data safety monitoring committee. He will take on an additional role on the Children’s Hospital of Orange County (CHOC)/UCI Research Collaboration Committee. At the National Clinical Trials Network (NCTN) level, Dr. Harris will continue his membership roles on SWOG and NRG Committees - SWOG Sarcoma Working Group, SWOG Radiation Oncology Committee, SWOG Early Therapeutics and Rare Cancers Committee, NRG Sarcoma Working Group, and NRG Developmental Therapeutics RT Committee. Clinical Trial Enrollment and Completion. Dr. Harris led the first two investigator-initiated trials in the Department of Radiation Oncology at UCI – one for sarcoma (UCI 21-03, NCT05488366, funded through the UCI Anti-Cancer Challenge Grant under NCI P30CA062203) and another for lung metastases (UCI 21-222, NCT05555342, funded through the American Cancer Society Seed Grant). UCI 21-03 tests the combination pembrolizumab with radiation therapy. During the ECIA period, Dr. Harris will complete trial accrual, perform analysis, and submit the manuscript. S2505 is a SWOG concept that Dr. Harris chairs: “Phase III Randomized Study Testing Non-Inferiority of Shorter-Course Radiation Versus Standard Fractionation for High-Risk, Resectable Sarcoma”. S2505 will be submitted to NIH CTEP prior to ECIA period. In Year 1 the protocol will be drafted, and in Year 2 site initiation and central radiation plan review will take place. Opening new NCTN trials at UCI. Dr. Harris will open EA7201 and ARST2031 at UCI. Expanding awareness of sarcoma clinical trials. UCI: Dr. Harris will take on a new role in the Sarcoma Tumor Board including a monthly overview of all open, accruing, and upcoming clinical trials in sarcoma to expand awareness and increase enrollment. Community: Dr. Harris will co-develop culturally tailored educational talks on clinical trials with the office of Community Outreach and Engagement. He will deliver these talks and emphasize how clinical trials offer treatment options for common cancers plus rare cancers like sarcomas.