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

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ClinicalTrials.gov Identifier: NCT02407795
Recruitment Status : Suspended
First Posted : April 3, 2015
Last Update Posted : January 29, 2018
Sponsor:
Collaborators:
Koningin Wilhelmina Fonds
Maastro Clinic, The Netherlands
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Spinal Metastases Radiation: conventional radiotherapy Radiation: stereotactic radiotherapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
Actual Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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




Primary Outcome Measures :
  1. Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire [ Time Frame: At six weeks since baseline ]
    Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire


Secondary Outcome Measures :
  1. Comparison of time to pain response [ 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 ]
    Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire

  2. Duration of pain relief [ 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 ]
    Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire

  3. Quality of life [ 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 ]
    EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires

  4. Toxicity measured by CTCAE 4.0 questionnaire [ Time Frame: up to months 12 ]
    Toxicity measuredCTCAE 4.0 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407795


Locations
Netherlands
Radiotherapiegroep Arnhem
Arnhem, Netherlands, 6815 AD
Medisch Centrum Haaglanden
Den Haag, Netherlands
Radiotherapiegroep Deventer
Deventer, Netherlands, 7416 SE
MAASTRO clinic
Maastricht, Netherlands, 6229 ET
Radboudumc Nijmegen
Nijmegen, Netherlands
Isala
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Radboud University
Koningin Wilhelmina Fonds
Maastro Clinic, The Netherlands
Investigators
Principal Investigator: P Braam, MD Radboudumc Nijmegen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02407795     History of Changes
Other Study ID Numbers: NL45994.091.14
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:
stereotactic radiotherapy
pain reduction
quality of life

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes