Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

University Hospital, Ghent54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bone Metastases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 month after radiotherapy

Secondary Outcomes

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).

Time frame: 1 Month after radiotherapy