Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

This study is currently recruiting participants.
Verified August 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01429493
First received: September 2, 2011
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Bone Metastases
Radiation: Conventional Radiotherapy
Radiation: Biological image-guided radiotherapy with conventional dose.
Radiation: Biological image-guided SBRT with dose-escalation.
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Level of pain response 1 month after radiotherapy [ Time Frame: 1 month after radiotherapy ] [ Designated as safety issue: No ]
    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:
  • Quality of life 1 month after radiotherapy. [ Time Frame: 1 Month after radiotherapy ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional radiotherapy Radiation: Conventional Radiotherapy
Conventional radiotherapy will be used (8 Gy/ 1 fraction).
Experimental: Biological image-guided radiotherapy with conventional dose. Radiation: 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.
Experimental: Biological image-guided SBRT with dose-escalation. Radiation: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429493

Contacts
Contact: Piet Ost, MD 09/3323074 piet.ost@ugent.be

Locations
Belgium
University Hospital Antwerp Recruiting
Antwerp, Belgium
Contact: Dirk Van Gestel, M.D.         
Principal Investigator: Dirk Van Gestel, M.D.         
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Wilfried De Neve, MD, PhD    +32(0)93323074 ext +32    wilfried.deneve@uzgent.be   
Principal Investigator: Wilfried De Neve, MD, PhD         
Sub-Investigator: Christophe Vandewiele, MD, PhD         
Sub-Investigator: Indira Madani, MD         
Sub-Investigator: Piet Ost, PhD, MD         
Sub-Investigator: Bruno De Potter, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01429493     History of Changes
Other Study ID Numbers: 2011/541
Study First Received: September 2, 2011
Last Updated: August 8, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014