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Brief Title: Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
Official Title: A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
Study ID: NCT02407795
Brief Summary: A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.
Detailed Description: Study population: patients with painful spinal metastases from solid tumors without spinal cord compression or cord instability. Objective: This study will test the hypothesis that stereotactic radiotherapy gives a better and longer lasting reduction of pain, local control and therewith a better quality of life. This in order to optimize and to individualize the treatment options for the patient. Study design: Complaints due to pain will be analysed using the validated Dutch Brief Pain Inventory (BPI) and side-effects will be recorded using the Common Toxicity Criteria for Adverse Events (CTCAE). In addition to this the quality of life will be analysed using the EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires. For analysis of cost-effectiveness the EQ-5D will be used.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Radiotherapiegroep Arnhem, Arnhem, , Netherlands
Medisch Centrum Haaglanden, Den Haag, , Netherlands
Radiotherapiegroep Deventer, Deventer, , Netherlands
MAASTRO clinic, Maastricht, , Netherlands
Radboudumc Nijmegen, Nijmegen, , Netherlands
Isala, Zwolle, , Netherlands
Name: P Braam, MD
Affiliation: Radboudumc Nijmegen
Role: PRINCIPAL_INVESTIGATOR