Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

Phase 2

Completed

• Conditions: Bone Metastases
• Interventions: Radiation: Biological image-guided SBRT with dose-escalation.; Radiation: Biological image-guided radiotherapy with conventional dose.; Radiation: Conventional Radiotherapy

• Registration Number: NCT01429493
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Study Start: 2013-02
• Primary Completion: 2015-05
• Study Completion: 2015-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological image-guided SBRT with dose-escalation.	Biological image-guided SBRT with dose-escalation.	-
Biological image-guided radiotherapy with conventional dose.	Biological image-guided radiotherapy with conventional dose.	-
Conventional radiotherapy	Conventional Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Level of pain response 1 month after radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life 1 month after radiotherapy.	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).

Trial Locations

Locations (2)

Ghent University Hospital; 🇧🇪 Ghent, Belgium

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium