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Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

NCT ID: NCT01429493

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional radiotherapy

Group Type ACTIVE_COMPARATOR

Conventional Radiotherapy

Intervention Type RADIATION

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

Biological image-guided radiotherapy with conventional dose.

Group Type EXPERIMENTAL

Biological image-guided radiotherapy with conventional dose.

Intervention Type 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.

Group Type EXPERIMENTAL

Biological image-guided SBRT with dose-escalation.

Intervention Type RADIATION

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

Interventions

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Conventional Radiotherapy

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

Intervention Type 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.

Intervention Type 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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilfried De Neve, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Antwerp

Antwerp, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Related Info

Other Identifiers

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2011/541

Identifier Type: -

Identifier Source: org_study_id