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very slow inclusion
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| Name | Class |
|---|---|
| Koningin Wilhelmina Fonds | OTHER |
| Maastro Clinic, The Netherlands | OTHER |
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A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Conventional radiotherapy, 1x8Gy |
|
| Arm 2 | Experimental | Stereotactic radiotherapy, 1x20Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional radiotherapy | Radiation | 1x8Gy |
| |
| stereotactic radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of pain relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| P Braam, MD | Radboudumc Nijmegen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapiegroep Arnhem | Arnhem | 6815 AD | Netherlands | |||
| Radiotherapiegroep Deventer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26829933 | Derived | 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. |
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| Radiation |
1x20Gy or equivalent dose fractionation schedule |
|
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 |
| 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 |
| Toxicity measured by CTCAE 4.0 questionnaire | Toxicity measuredCTCAE 4.0 questionnaire | up to months 12 |
| Deventer |
| 7416 SE |
| Netherlands |
| MAASTRO clinic | Maastricht | 6229 ET | Netherlands |
| Radboudumc Nijmegen | Nijmegen | Netherlands |
| Medisch Centrum Haaglanden | The Hague | Netherlands |
| Isala | Zwolle | 8025 AB | Netherlands |
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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