Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01429493

Enrollment

Registered

2011-09-07

Start date

2013-02-28

Completion date

2015-12-31

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases

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.

Interventions

RADIATIONConventional Radiotherapy

Conventional radiotherapy will be used (8 Gy/ 1 fraction).

RADIATIONBiological 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.

RADIATIONBiological image-guided SBRT with dose-escalation.

Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026