A distinguishing feature of this clinical trial is the reporting of study outcomes online and in real-time, as study participants are followed clinically and results are reported to the study coordinator.  In most other clinical trials, results are not disclosed until months or years after patient recruitment to the study begins and often not until long after the trial has ended.  Investigators in this study wish for all results, including information relating to therapy response, survival, and adverse events, if any, to be disclosed immediately to patients, physicians, and others.  This will be highly advantageous to patients as they contemplate entry into the trial.  It will also enable physicians to assess the clinical activities of drugs, including new drugs and novel drug combinations, which are identified within the context of the study long before such information normally is made available in other clinical studies.

 

Responses to therapy reported herein are determined by means of physical exam, palliation of symptoms, biomarkers of disease, radiology, blood counts, and other qualitative and quantitative measures which are widely-accepted within a specific cancer diagnosis.  

 

Any adverse events which might occur will be reported frankly and immediately.  Such events will be classified as mild, moderate, or severe in accordance with standard terminology and assessment criteria.