Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

Study Overview
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Brief Summary
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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.

Official Title
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Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial

Conditions
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Bone Metastases

Intervention / Treatment
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* Radiation: Conventional Radiotherapy
* Radiation: Biological image-guided radiotherapy with conventional dose.
* Radiation: Biological image-guided SBRT with dose-escalation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Painful bone metastasis of solid tumors Pain score minimum of 2 on a scale of 10 A maximum number of painful bone metastases: 3 or more Life expectancy > 3 months Age minimum 18 years old Signed informed consent Exclusion Criteria: Tumor histology (renal cell and melanoma vs. other solid tumors) VAS pain score (<5 vs. 6-10). Bisphosphonate use (yes vs. no) Opioid analgesics (yes vs. no) Corticosteroid use (yes vs. no) Spine vs non-spine localisation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional radiotherapy<br> | Radiation: Conventional Radiotherapy<br>* Conventional radiotherapy will be used (8 Gy/ 1 fraction).<br>|
| Experimental: Biological image-guided radiotherapy with conventional dose.<br> | Radiation: Biological image-guided radiotherapy with conventional dose.<br>* Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used.<br>|
| Experimental: Biological image-guided SBRT with dose-escalation.<br> | Radiation: Biological image-guided SBRT with dose-escalation.<br>* Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |