NCT02407795

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

March 31, 2015

Last Update Submit

May 9, 2022

Conditions

Spinal Metastases

Keywords

stereotactic radiotherapypain reductionquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

  • 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

  • Toxicity measured by CTCAE 4.0 questionnaire

    up to months 12

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Conventional radiotherapy, 1x8Gy

Radiation: conventional radiotherapy

Arm 2

EXPERIMENTAL

Stereotactic radiotherapy, 1x20Gy

Radiation: stereotactic radiotherapy

Interventions

conventional radiotherapyRADIATION

1x8Gy

Arm 1
stereotactic radiotherapyRADIATION

1x20Gy or equivalent dose fractionation schedule

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Radiotherapiegroep Arnhem

Arnhem, 6815 AD, Netherlands

Location

Radiotherapiegroep Deventer

Deventer, 7416 SE, Netherlands

Location

MAASTRO clinic

Maastricht, 6229 ET, Netherlands

Location

Radboudumc Nijmegen

Nijmegen, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26829933DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • P Braam, MD

    Radboudumc Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2018

Study Completion

November 10, 2021

Last Updated

May 13, 2022

Record last verified: 2022-05

Locations

NL(6)