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

Not Applicable

Terminated

• Conditions: Spinal Metastases
• Interventions: Radiation: conventional radiotherapy; Radiation: stereotactic radiotherapy

• Registration Number: NCT02407795
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Study Start: 2015-05
• Primary Completion: 2018-08-01
• Study Completion: 2021-11-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• solid tumor with radiological diagnosis of spinal metastases
• pain score minimum 2 on 11-point scale
• maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor at current level of interest
• No or mild neurological signs (radiculopathy, dermatomal sensory change and muscle strength of involved extremity)
• Karnofsky performance ≥60
• WHO ≤2
• life expectancy > 6 weeks
• age ≥18
• non-pregnant, non-lactating female patients

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Exclusion Criteria

• history of previous radiotherapy to the spine at current level of interest
• spinal instability or neurological deficit
• pathological fracture or impending fracture needing fixation
• prior surgery to the spine at current level of interest
• clinical signs of spinal cord compression or severe neurological deficits
• patients with a pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
• patients unable to undergo MRI
• earlier nuclear medicine treatment
• pregnancy
• altered mental status that would prohibit the understanding and giving of informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	conventional radiotherapy	Conventional radiotherapy, 1x8Gy
Arm 2	stereotactic radiotherapy	Stereotactic radiotherapy, 1x20Gy

Primary Outcome Measures

Name	Time	Method
Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire	At six weeks since baseline	Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire

Secondary Outcome Measures

Name	Time	Method
Comparison of time to pain response	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	Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Duration of pain relief	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	Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Toxicity measured by CTCAE 4.0 questionnaire	up to months 12	Toxicity measuredCTCAE 4.0 questionnaire
Quality of life	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	EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires

Trial Locations

Locations (6)

Radiotherapiegroep Arnhem; 🇳🇱 Arnhem, Netherlands

Radiotherapiegroep Deventer; 🇳🇱 Deventer, Netherlands

Radboudumc Nijmegen; 🇳🇱 Nijmegen, Netherlands

Isala; 🇳🇱 Zwolle, Netherlands

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Netherlands

MAASTRO clinic; 🇳🇱 Maastricht, Netherlands