Phase II Trials--Determining whether the new treatment works.
The main goal of a Phase II trial is to examine how well the new treatment works to fight a certain kind of cancer. Fewer than 100 patients usually participate in a Phase II trial. In addition to evaluating how well the treatment works against the cancer, doctors continue to monitor patients' side effects. Since more patients participate in Phase II studies, researchers may discover new side effects that were not evident during the Phase I trials. If the new treatment seems to be effective against cancer in a certain percentage of patients, researchers may consider it successful enough to continue study in a Phase III clinical trial.
Usually patients who have already undergone chemotherapy, biotherapy, surgery, or radiation are eligible for a Phase II trial.
