Neoplasms

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Neoplasm Metastasis

Pain

Neoplastic Processes

Quality of Life

conventional radiotherapy

1x20Gy or equivalent dose fractionation schedule

stereotactic radiotherapy

P Braam, MD

A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.

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.

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)

Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire

EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases	NCT02407795	Spinal Metastas...	conventional ra... stereotactic ra...	18 Years -	Radboud University Medical Center
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases	NCT02407795	Spinal Metastas...	conventional ra... stereotactic ra...	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for pain reduction