关键词:腺癌;患者;治疗
摘 要:The PT-304 study was prematurely terminated on October 1, 2012 primarily due to Precision receiving non-coverage forIn Vitro Chemosensitivity & Chemoresistance Asssays from Medicare. Additionally, our attempts to increase patient accrual throughout the duration of the study were unmet and ultimately the lack of subject recruitment negatively impacted the success of this study. A total of three-hundred-eighty-five (385) specimens were received by Precision accounting for both pre-treatment and post-treatment samples. Of the specimens received one-hundred-eighty-three (183) were terminated and one-hundred-twelve (112) were screen failures, the remaining two-hundred-two (202) specimens had drug assays completed of which the success rate following quality control was sixty percent. Three-hundred-twenty-seven (327) subjects were enrolled in the trial of which only one-hundred-thirty-four (134) were deemed evaluable. Upon notifying sites of the termination all active subjects were discontinued from participation. A total of thirty Principal Investigators were approved by the DoD to participate in this study, six investigator sites were prematurely closed prior to the termination of the study notification sent on October 1, 2012. Eleven additional sites have been officially closed with IRBs following the termination of the project and the remaining thirteen sites are in the process of closing. All sites are expected to be officially closed by the end of the calendar year with the Department of Defense.