THE NEED FOR IMMEDIATE MONITORING OF TREATMENT PARAMETERS AND UNIFORM ASSESSMENT OF PATIENT DATA IN CLINICAL-TRIALS - A QUALITY-CONTROL STUDY OF THE EORTC RADIOTHERAPY AND LUNG-CANCER COOPERATIVE GROUPS

A quality control study was performed during the EORTC phase III study 08844: radiotherapy combined with low dose cisplatin (cDDP) in inoperable non-metastatic non-small cell lung cancer. Radiation alone (55 Gy, split course) was compared to radiotherapy with 30 mg/m2 cisplatin once a week and to radiotherapy with 6 mg/m2 cisplatin daily. The purpose of the control study was to check to which degree protocol guidelines were followed and to measure the extent of differences in assessment of tumour response, recurrence and toxicities between the individual institutes. A review team, consisting of a data manager, a diagnostic radiologist, a chest physician and two radiotherapists reviewed entry criteria, treatment data, tumour responses, recurrences and late toxicity of 177 patients (a total of 300 patients was required for the trial). Only departments which had entered more than 5% of this number of patients were visited. There was a 15% difference in T staging of the patients and a 17% discrepancy in N stage scoring between the review team and the local investigators. Radiotherapy field sizes were insufficient in 15% of the eligible patients during a period of the radiotherapy; in another 17% patients the tumour free margin was less than 1 cm. Radiation doses were incorrectly given to 7% of the patients. The given doses of cisplatin deviated in 10% of the patients treated with combined modalities. The interpretation of chest X-rays and computed tomography (CT) showed important differences in tumour response, tumour recurrence and late toxicity. From these data it is concluded that immediate checks can detect errors in treatments as planned at the local level and will make corrections possible at an early stage in multicentre studies. The quality of trial results will thus be improved. Uniform assessment of treatment outcome, tumour progression and forms of toxicity will lead to more sound trial conclusions.