International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases

Purpose: To reach a consensus on a set of optimal endpoint measurements for future external beam radiotherapy trials in bone metastases. Methods: An International Bone Metastases Consensus Working Party invited principal investigators and individuals with a recognized interest in bone metastases to participate in the two surveys and a panel meeting on their preference of choice of optimal endpoints. Results: Consensus has been reached on the following: (a) eligibility criteria for future trials; (b) pain and analgesic assessments; (c) radiation techniques; (d) follow-up and timing of assessments; (e) parameters at follow-up; (f) endpoints; (g) re-irradiation; and (h) statistical analysis. Conclusions: Based on the available literature and the clinical experience of the working party members, an acceptable set of endpoints has been agreed upon for future clinical trials to promote consistency in reporting. It is intended that the consensus will be re-examined every 5 years. Areas of further research were identified. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.