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

Primary Purpose

Spinal Metastases

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
conventional radiotherapy
stereotactic radiotherapy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Metastases focused on measuring stereotactic radiotherapy, pain reduction, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiotherapiegroep Arnhem
  • Medisch Centrum Haaglanden
  • Radiotherapiegroep Deventer
  • MAASTRO clinic
  • Radboudumc Nijmegen
  • Isala

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Conventional radiotherapy, 1x8Gy

Stereotactic radiotherapy, 1x20Gy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2015
Last Updated
May 9, 2022
Sponsor
Radboud University Medical Center
Collaborators
Koningin Wilhelmina Fonds, Maastro Clinic, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT02407795
Brief Title
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
Acronym
RACOST
Official Title
A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
very slow inclusion
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Koningin Wilhelmina Fonds, Maastro Clinic, The Netherlands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
stereotactic radiotherapy, pain reduction, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Conventional radiotherapy, 1x8Gy
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Stereotactic radiotherapy, 1x20Gy
Intervention Type
Radiation
Intervention Name(s)
conventional radiotherapy
Intervention Description
1x8Gy
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiotherapy
Intervention Description
1x20Gy or equivalent dose fractionation schedule
Primary Outcome Measure Information:
Title
Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire
Description
Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Time Frame
At six weeks since baseline
Secondary Outcome Measure Information:
Title
Comparison of time to pain response
Description
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
Title
Duration of pain relief
Description
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
Title
Quality of life
Description
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
Title
Toxicity measured by CTCAE 4.0 questionnaire
Description
Toxicity measuredCTCAE 4.0 questionnaire
Time Frame
up to months 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P Braam, MD
Organizational Affiliation
Radboudumc Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiotherapiegroep Arnhem
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
Den Haag
Country
Netherlands
Facility Name
Radiotherapiegroep Deventer
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
MAASTRO clinic
City
Maastricht
ZIP/Postal Code
6229 ET
Country
Netherlands
Facility Name
Radboudumc Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26829933
Citation
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.
Results Reference
derived

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

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