Clinical trial NCT02407795: Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
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
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Metastases
Keywords: stereotactic radiotherapy
pain reduction
quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Koningin Wilhelmina Fonds
name: Maastro Clinic, The Netherlands
First posted: 2015-04-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire
timeFrame: At six weeks since baseline
Secondary outcomes:
measure: Comparison of time to pain response
timeFrame: 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
measure: Duration of pain relief
timeFrame: 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
measure: Quality of life
timeFrame: 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
measure: Toxicity measured by CTCAE 4.0 questionnaire
timeFrame: up to months 12
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep Arnhem
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden
city: Deventer
country: Netherlands
facility: Radiotherapiegroep Deventer
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
city: Nijmegen
country: Netherlands
facility: Radboudumc Nijmegen
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Radboudumc Nijmegen
name: P Braam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.