Spinal Metastases Clinical Trial
— RACOSTOfficial title:
A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
Verified date | May 2022 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.
Status | Terminated |
Enrollment | 25 |
Est. completion date | November 10, 2021 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radiotherapiegroep Arnhem | Arnhem | |
Netherlands | Medisch Centrum Haaglanden | Den Haag | |
Netherlands | Radiotherapiegroep Deventer | Deventer | |
Netherlands | MAASTRO clinic | Maastricht | |
Netherlands | Radboudumc Nijmegen | Nijmegen | |
Netherlands | Isala | Zwolle |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Koningin Wilhelmina Fonds, Maastro Clinic, The Netherlands |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Toxicity measured by CTCAE 4.0 questionnaire | Toxicity measuredCTCAE 4.0 questionnaire | up to months 12 |
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