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In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional radiotherapy | Active Comparator |
| |
| Biological image-guided radiotherapy with conventional dose. | Experimental |
| |
| Biological image-guided SBRT with dose-escalation. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Radiotherapy | Radiation | Conventional radiotherapy will be used (8 Gy/ 1 fraction). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain response 1 month after radiotherapy | Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy. | 1 month after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life 1 month after radiotherapy. | Quality of life 1 month after radiotherapy measured with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Bone Metastases Module (QLQ-BM22). | 1 Month after radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Neve, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Antwerp | Belgium | ||||
| Ghent University Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Biological image-guided radiotherapy with conventional dose. | Radiation | Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used. |
|
| Biological image-guided SBRT with dose-escalation. | Radiation | Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used. |
|
| Ghent |
| 9000 |
| Belgium |