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Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

NCT01429493 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-12-16

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Conventional Radiotherapy

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

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.

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.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wilfried De Neve, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429493 on ClinicalTrials.gov