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

Spinal Metastases Clinical Trial

— RACOST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02407795
• Other study ID #: NL45994.091.14
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 10, 2021

Study information

• Verified date: May 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 10, 2021
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Radiation:
• conventional radiotherapy
1x8Gy
• stereotactic radiotherapy
1x20Gy or equivalent dose fractionation schedule

Locations

Country	Name	City	State
Netherlands	Radiotherapiegroep Arnhem	Arnhem
Netherlands	Medisch Centrum Haaglanden	Den Haag
Netherlands	Radiotherapiegroep Deventer	Deventer
Netherlands	MAASTRO clinic	Maastricht
Netherlands	Radboudumc Nijmegen	Nijmegen
Netherlands	Isala	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University Medical Center	Koningin Wilhelmina Fonds, Maastro Clinic, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At six weeks since baseline
Secondary	Comparison of time to pain response	Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire	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
Secondary	Duration of pain relief	Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire	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
Secondary	Quality of life	EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires	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
Secondary	Toxicity measured by CTCAE 4.0 questionnaire	Toxicity measuredCTCAE 4.0 questionnaire	up to months 12