Rationale for a quality assurance programme in clinical trials of conservative management of breast carcinoma. European Organization for the Research and Treatment of Cancer.

Abstract

The EORTC Consensus Meeting held at Tübingen on 13-14 December, 1990 reviewed the treatment sequence in conservative management of early breast cancer from the standpoint of quality assurance. These reports considered the most relevant criteria for evaluating pathology, surgery and radiotherapy techniques, not only for selected institutions participating in prospective randomised trials but also aiming at developing quality control procedures that could be used anywhere for routine standard treatment. This paper lists the various steps justifying quality control procedures in radiotherapy of the breast and actions to be taken according to the score of observed deviations. At last, it includes a discussion of the justification of quality control and of its potential consequences on the results of trial in the EORTC trial 22881/10882 (boost treatment versus no boost in conservative management of early breast cancer) in which the accrual of 1500 patients is planned.