Spinal MetastasesRACOSTNCT02407795
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
A study testing conventional radiotherapy and stereotactic radiotherapy in people with Spinal Metastases, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- conventional radiotherapy and stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesNetherlands
- Study dates
- May 2015to 10 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- life expectancy > 6 weeks
- age ≥18
- non-pregnant, non-lactating female patients
Who cannot join
- 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
Show all 10Show fewer
- patients unable to undergo MRI
- earlier nuclear medicine treatment
- pregnancy
- altered mental status that would prohibit the understanding and giving of informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Radiotherapiegroep Arnhem
Arnhem, 6815 AD
Radiotherapiegroep Deventer
Deventer, 7416 SE
MAASTRO clinic
Maastricht, 6229 ET
Radboudumc Nijmegen
Nijmegen
Medisch Centrum Haaglanden
The Hague
Isala
Zwolle, 8025 AB
About this study
Official title: A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.
Read the 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.
- Conditions
- Spinal Metastases
- Being tested
- conventional radiotherapy, stereotactic radiotherapy
- Keywords
- stereotactic radiotherapy, pain reduction, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional radiotherapyRadiation
1x8Gy
stereotactic radiotherapyRadiation
1x20Gy or equivalent dose fractionation schedule
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Conventional radiotherapy, 1x8Gy Receives: Radiation: conventional radiotherapy |
| Arm 2 | Experimental | Stereotactic radiotherapy, 1x20Gy Receives: Radiation: stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At six weeks since baseline
Secondary outcomes (4)
Comparison of time to pain response
Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Measured: 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 is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
Measured: 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
EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires
Measured: 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
Toxicity measuredCTCAE 4.0 questionnaire
Measured: up to months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion1 Aug 2018
- Study completion10 Nov 2021
Why it stopped: very slow inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Koningin Wilhelmina Fonds, Maastro Clinic, The Netherlands
- Responsible party
- Sponsor
- Investigators
- P Braam, MD, Principal investigator, Radboudumc Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407795
- Sponsor's protocol ID
- NL45994.091.14
- Acronym
- RACOST
- Status last verified
- May 2022
- First submitted
- 31 Mar 2015
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26829933
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
- ClinicalTrials.gov ID
- NCT02407795
- Acronym / sponsor ID
- RACOST / NL45994.091.14
- Conditions
- Spinal Metastases
- Keywords
- stereotactic radiotherapy, pain reduction, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very slow inclusion
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Koningin Wilhelmina Fonds, Maastro Clinic, The Netherlands
- Study start
- May 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Radiation: conventional radiotherapyConventional radiotherapy, 1x8Gy |
| Arm 2 | Experimental | Radiation: stereotactic radiotherapyStereotactic radiotherapy, 1x20Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional radiotherapy1x8Gy | Radiation | Arm 1 |
| stereotactic radiotherapy1x20Gy or equivalent dose fractionation schedule | Radiation | Arm 2 |
Primary outcome
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
4 secondary outcomes
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
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
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
Toxicity measured by CTCAE 4.0 questionnaire
Time frame: up to months 12
Results and safety
The study was stopped early (reason given: very slow inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 26829933Braam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P Braam, MD principal investigator
Radboudumc Nijmegen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional radiotherapy and stereotactic radiotherapy in people with Spinal Metastases, run by Radboud University Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: very slow inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire (time frame: At six weeks since baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.