Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429493
• Other study ID #: 2011/541
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Conventional Radiotherapy
Conventional radiotherapy will be used (8 Gy/ 1 fraction).
• Biological image-guided radiotherapy with conventional dose.
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.
Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Related Info