This Core will address (1) information management for clinical and physics projects, (2) treatment planning and delivery issues related to bi-institutional collaborative trials, and (3) statistical issues. The tasks will be coordinated by the Core Directors, Michael Gillin, Ph.D., and Beow Yeap, Sc.D., and the Co-Investigators. The management of this Core will be a team effort, with each investigator contributing within their area of specialization. The team will use two different information management systems for clinical studies. Team members at Massachusetts General Hospital (MGH) will operate the """"""""Trial DB"""""""" patient-specific non-DICOM information management system for registering and randomizing patients. Secondly, both institutions will use a database management system for DICOM-RT objects operated by the Image-guided Therapy QA Center (ITC) at Washington University (WU) in St. Louis. The second database system is necessary because Trial DB does not manage DICOM objects. Members of the team at M. D. Anderson Cancer Center (MDACC) will use a system called Evercore to manage DICOM and NON-DICOM databases for studies in physics (Projects 3 and 4). MGH and MDACC have substantial experience in cooperative group activities and will address treatment planning and delivery issues of relevance to proton therapy trials in a bi-institutional setting in a manner consistent with the high standards of established cooperative groups. Explicit issues addressed in this Core include proton beam calibration, treatment delivery quality assessment programs, CT-based treatment planning using both commercial and Monte Carlo approaches, and protocol compliance. Team members from MGH and MDACC agree to work with the Radiological Physics Center, which will provide an independent review of treatment planning and treatment delivery systems used in this program project. Our experience with trials in the bi-institutional settings should serve as the basis to define standards for the use of protons in multi-institutional trials. The knowledge gained will be communicated to cooperative groups for their consideration.
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