Problems in carrying out the prospective clinical trial of III rd phase

Abstract

In 1994 the project multicenter studies has been elaborated.

Objectives

Implementation of QA standards in radiotherapy of laryngeal carcinoma irradiated in eight radiotherapy centers (muiticenter study) in Poland.

The elaboration of study design and practical implementation of multicenter prospective studies (clinical trial).

Rationale

The QA standards are at present most important subject of activities in radiotherapy both in practice and in research. The improvement in QA can result in improvement of the outcomes of treatment and decrease the risk of postirradiation damage.

The retrospective analyses of several materials of head and neck cancers treated with irradiation indicated the detrimental effect of prolongation of overall-treatment-time.

The numerical values of this effect presented in the literature are often in disagreement with clinical every-day experience. The elucidation of this problem in prospective studies (clinical trial) can be of cognitive and practical value.

It is the first attempt in organizing clinical trial on such a scale in Polish radiotherapy. The participating centers give the radiotherapy services to the population of about 20 min. people.

The problems in collecting data to hold out the standards in documentation, in follow-up and benefis observed in the mid-course of this study will be discussed.