NCT02407795

Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases

A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Metastases

Interventions

Type	Name	Description
RADIATION	conventional radiotherapy	1x8Gy
RADIATION	stereotactic radiotherapy	1x20Gy or equivalent dose fractionation schedule

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-08-01
• Completion: 2021-11-10
• First posted: 2015-04-03
• Last updated: 2022-05-13

Locations

6 sites across 1 country: Netherlands