Skip to main content
OpenTrials
Completed

NCT Number: NCT01429493

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Antwerp, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional radiotherapy

Radiation

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

Biological image-guided radiotherapy with conventional dose.

Radiation

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.

Radiation

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

Primary outcomes

  1. Level of pain response 1 month after radiotherapy

    Time frame: 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 outcomes

  1. Quality of life 1 month after radiotherapy.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2011
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.