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

NCT02358720 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-02-09

No results posted yet for this study

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).

Conditions

Interventions

RADIATION

Arm A

1x24Gy high dose IMRT on spinal bone metastasis

RADIATION

Arm B

fractionated conformal RT 10 x 3 Gy on spinal bone metastasis

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Harald Rief, MD, PhD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT02358720 on ClinicalTrials.gov