Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases
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|ClinicalTrials.gov Identifier: NCT01429493|
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : September 7, 2011
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
|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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429493
|Contact: Piet Ost, MDfirstname.lastname@example.org|
|University Hospital Antwerp||Recruiting|
|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 email@example.com|
|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|
|Principal Investigator:||Wilfried De Neve, MD, PhD||University Hospital, Ghent|