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

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

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 Overview

• Status: Terminated
• Conditions: Spinal Metastases
• Intervention / Treatment: Radiation: conventional radiotherapy; Radiation: stereotactic radiotherapy

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Radiotherapiegroep Arnhem
  • Den Haag, Netherlands
    • Medisch Centrum Haaglanden
  • Deventer, Netherlands, 7416 SE
    • Radiotherapiegroep Deventer
  • Maastricht, Netherlands, 6229 ET
    • Maastro clinic
  • Nijmegen, Netherlands
    • Radboudumc Nijmegen
  • Zwolle, Netherlands, 8025 AB
    • Isala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Conventional radiotherapy, 1x8Gy	Radiation: conventional radiotherapy; 1x8Gy
Experimental: Arm 2; Stereotactic radiotherapy, 1x20Gy	Radiation: stereotactic radiotherapy; 1x20Gy or equivalent dose fractionation schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Toxicity measured by CTCAE 4.0 questionnaire	Toxicity measuredCTCAE 4.0 questionnaire	up to months 12

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Koningin Wilhelmina Fonds; Maastro Clinic, The Netherlands
• Investigators: Principal Investigator: P Braam, MD, Radboudumc Nijmegen

Publications and helpful links

General Publications

• Braam P, Lambin P, Bussink J. Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:61. doi: 10.1186/s13063-016-1178-7.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; pain reduction; stereotactic radiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: NL45994.091.14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No