Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases
|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).
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|