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

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 Overview

• Status: Unknown
• Conditions: Bone Metastases
• Intervention / Treatment: Radiation: Conventional Radiotherapy; Radiation: Biological image-guided radiotherapy with conventional dose.; Radiation: Biological image-guided SBRT with dose-escalation.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Recruiting
    • University Hospital Antwerp
    • Contact: Dirk Van Gestel, M.D.
    • Principal Investigator: Dirk Van Gestel, M.D.
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Wilfried De Neve, MD, PhD; Phone Number: +32 +32(0)93323074; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 2, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: 2011/541