Have there been controlled clinical trials to prove that CCDRT improves the results of cancer chemotherapy?
There have been four prospective, controlled, but non-randomized clinical trials which have been published. In addition, there has been one prospective, controlled, randomized trial presented at a cancer meeting, but not yet published. Finally, there is a large, prospective randomized trial in progress in chronic lymphocytic leukemia, which has not yet been reported even as a meeting abstract, but which has reached its patient accrual goals, so that results should be available at some point in the future. In breast cancer, 73 patients with advanced disease received assay-directed therapy, while 73 control patients received “physician’s choice” chemotherapy. The assay-directed group had a significantly higher response rate (77% vs. 44%) and a trend for improved overall survival, which was not statistically significant, owing to the relatively small number of patients entered onto the clinical trial (it has often taken between 2,000 and 50,000 patients to “prove” statistical significance