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The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.
Rationale: Bone metastases are a frequent distant manifestation of solid tumours, and many bone metastases are located in the spine. These patients mostly present with severe (back) pain which reduces quality of life. The primary treatment for pain management is a single-fraction low dose external beam radiation therapy (EBRT), effective in achieving pain reduction in around 60% of patients, of whom 0-23% experience complete pain response. Recently, there is growing evidence that Stereotactic Body Radiotherapy (SBRT) achieves a much higher pain response due to the higher dose administered. In retrospective and a few prospective case series, SBRT for spinal, and also non-spinal metastases has been demonstrated to be safe, and efficacious. However, no randomized controlled trials have been performed.
Objective: To study whether the pain response after three months in patients with osseous metastatic disease increases after SBRT in comparison to low dose EBRT.
Study design: Randomized controlled trial, the VERTICAL study, nested within the PRESENT cohort.
Study population: Eligible patients are MRI-compatible patients with radiographic evidence of bone metastases at the radiotherapy department. Fifty-five patients are recruited in both control and intervention arm.
Intervention: Patients will undergo MRI-based, cone beam CT-guided SBRT and will receive a single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony compartment containing the metastasis (e.g. the affected vertebra or pedicle).
Main study parameters/endpoints: The primary endpoint is pain control at three months after radiotherapy. Secondary outcomes are, among others, the occurrence of vertebral compression fracture (VCF) and radiation-induced myelopathy, local tumour control and evaluation of quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | MRI-based, cone beam CT-guided SBRT delivery of a single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony compartment containing the metastasis (e.g. the affected vertebra or pedicle). |
|
| Conventional Radiotherapy | No Intervention | Delivery of a single fraction of 8 Gy using virtual simulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete or partial pain response after radiation, defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials. | The primary endpoint of this study is complete or partial pain response after SBRT or EBRT after three months. Complete and partial response, but also possible pain progression or indeterminate response, will be defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life | Self reported quality of life as measured by the Brief Pain Inventory, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C15-PAL, and EORTC QLQ BM22 | at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena M. Verkooijen, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | 3508 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33333200 | Derived | Pielkenrood BJ, van der Velden JM, van der Linden YM, Bartels MMT, Kasperts N, Verhoeff JJC, Eppinga WSC, Gal R, Verlaan JJ, Verkooijen HML. Pain Response After Stereotactic Body Radiation Therapy Versus Conventional Radiation Therapy in Patients With Bone Metastases-A Phase 2 Randomized Controlled Trial Within a Prospective Cohort. Int J Radiat Oncol Biol Phys. 2021 Jun 1;110(2):358-367. doi: 10.1016/j.ijrobp.2020.11.060. Epub 2020 Dec 14. | |
| 27871280 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Progression free survival is defined as time between treatment and first sign of progression of disease |
| up to 3 years |
| Overall survival | Overall survival is defined as time between treatment and death from any cause | up to 3 years |
| Occurrence or progression of vertebral compression fracture (VCF) | VCF is defined as new endplate fracture or collapse deformity as compared with before SBRT or EBRT | up to 12 months |
| Occurrence of radiation-induced myelopathy | Radiation-induced myelopathy is defined as a diagnosis of exclusion and defined as neurological signs and symptoms consistent with radiation damage in the form of necrosis to the segment of the spinal cord irradiated, without MRI evidence of recurrent or progressive tumour affecting the spinal cord. | up to 12 months |
| Duration of pain relief | Duration of pain relief as measured by the Brief Pain Inventory | at 2, 4, 6, 8 weeks, 3 and 6 months |
| Determination of rapidity of pain relief | Rapidity of pain relief as measured by the Brief Pain Inventory | at 2, 4, 6, 8 weeks, 3 and 6 months |
| Derived |
| van der Velden JM, Verkooijen HM, Seravalli E, Hes J, Gerlich AS, Kasperts N, Eppinga WS, Verlaan JJ, van Vulpen M. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design. BMC Cancer. 2016 Nov 21;16(1):909. doi: 10.1186/s12885-016-2947-0. |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |