Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases
1 other identifier
interventional
54
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2013
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 16, 2022
December 1, 2022
2.2 years
September 2, 2011
December 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of life 1 month after radiotherapy.
1 Month after radiotherapy
Study Arms (3)
Conventional radiotherapy
ACTIVE COMPARATORBiological image-guided radiotherapy with conventional dose.
EXPERIMENTALBiological image-guided SBRT with dose-escalation.
EXPERIMENTALInterventions
Conventional radiotherapy will be used (8 Gy/ 1 fraction).
Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used.
Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Antwerp
Antwerp, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Wilfried De Neve, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 7, 2011
Study Start
February 1, 2013
Primary Completion
May 1, 2015
Study Completion
December 1, 2015
Last Updated
December 16, 2022
Record last verified: 2022-12