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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
25
1x8Gy
1x20Gy or equivalent dose fractionation schedule
Radiotherapiegroep Arnhem
Arnhem, Netherlands
Radiotherapiegroep Deventer
Deventer, Netherlands
MAASTRO clinic
Maastricht, Netherlands
Radboudumc Nijmegen
Nijmegen, Netherlands
Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire
Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Time frame: At six weeks since baseline
Comparison of time to pain response
Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Time frame: pain response is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12
Duration of pain relief
Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Time frame: Pain relief is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12
Quality of life
EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires
Time frame: Quality of life is calculated from the date of randomization at day 0, 7, 14, week 4, 6, and month 2, 3, 4, 6, 9, and 12
Toxicity measured by CTCAE 4.0 questionnaire
Toxicity measuredCTCAE 4.0 questionnaire
Time frame: up to months 12
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Medisch Centrum Haaglanden
The Hague, Netherlands
Isala
Zwolle, Netherlands