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Single-fraction IMRT Versus External Beam Radiotherapy for Patients With Spine Bone Metastases (SMART)

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ClinicalTrials.gov Identifier: NCT02358720
Recruitment Status : Unknown
Verified February 2015 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Heidelberg University

Brief Summary:
This study is a prospective, randomized, monocentre, controlled explorative study in the parallel-group design to determine the pain relief after RT of patients with spinal bone metastases. Thereby two different techniques were evaluated: single fraction IMRT with 1 x 24 Gy versus fractionated RT with 10 x 3 Gy. Prior to their enrolment into the study, the patients will undergo a staging of the vertebral column in connection with their radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After the baseline results have been recorded, the patients will be randomized into one of the two groups: single-fraction IMRT 1 x 24 Gy (n = 30) or fractionated RT 10 x 3 Gy (n = 30). The target parameters will be measured and recorded at baseline, at the end of RT (t1) and twelve weeks (t2) and six months following the end of the irradiation period (t3).

Condition or disease Intervention/treatment Phase
Pain Radiation: Arm A Radiation: Arm B Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-fraction IMRT Versus External Beam Radiotherapy for Patients With Spine Bone Metastases
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: A: single fraction IMRT with 1 x 24 Gy
single fraction IMRT with 1 x 24 Gy on bone metastasis
Radiation: Arm A
1x24Gy high dose IMRT on spinal bone metastasis

Active Comparator: B: fractionated RT with 10 x 3 Gy
fractionated RT with 10 x 3 Gy on bone metastasis
Radiation: Arm B
fractionated conformal RT 10 x 3 Gy on spinal bone metastasis




Primary Outcome Measures :
  1. pain relief, as measured by visual analog scale (VAS) [ Time Frame: 3 months after therapy completed ]
    The primary endpoint was defined as pain relief > 2 points according to visual analog scale (VAS) measured at the irradiated region up to three months after the end of RT


Secondary Outcome Measures :
  1. quality of life measured on an EORTC BM22 questionnaire [ Time Frame: 3 and 6 months after therapy completed ]
    Secondary endpoints were quality of life (QoL) measured on an EORTC BM22 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a histologically confirmed tumor diagnosis, with secondary diagnosed solitary/multiple spinal bone metastases
  • Indication for RT of the spinal bone metastases
  • Maximal two irradiated vertebral-bodies per region
  • Maximal two different vertebral regions
  • Age: between 18 and 80 years
  • Karnofsky index (10) ≥ 70
  • Signed Declaration of Informed Consent
  • Tumor distance > 3 mm to myelon

Exclusion Criteria:

  • Multiple myeloma or lymphoma
  • Significant neurological or psychiatric disorders, including dementia and epileptic seizures
  • Earlier RT at the current irradiated site
  • Other severe disorders that in the judgement of the study director may prevent the patient's participation in the study
  • Lacking or diminished legal capacity
  • Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately
  • understand the scope of the study and to give his/her consent

Information from the National Library of Medicine

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): NCT02358720


Contacts
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Contact: Harald Rief, MD, PhD +496221568202 ext 0 harald.rief@med.uni-heidelberg.de

Locations
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Germany
Dept of Radiation Oncology, University of Heidelberg, Germany Recruiting
Heidelberg, Germany, 69120
Contact: Harald Rief, MD, PhD    +49-6221-56´- ext 8202    harald.rief@med.uni-heidelberg.de   
Principal Investigator: Harald Rief, MD, PhD         
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Harald Rief, MD, PhD University Hospital Heidelberg
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT02358720    
Other Study ID Numbers: SMART
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015
Keywords provided by Heidelberg University:
bone metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes