UnknownPhase 2

Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases

Germany60 participantsStarted 2016-08

Plain-language summary

The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each. Experimental intervention: IMRT 10 x 3 Gy Control intervention: 3D-RT 10 x 3 Gy

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a histologically confirmed tumor diagnosis and with secondary diagnosed solitary/multiple spinal bone metastases * Indication for RT of the spinal bone metastases * Age of between 18 and 85 years * Karnofsky index of at least 50 * Signed declaration of informed consent Exclusion Criteria: * Lymphoma * Significant neurological or psychiatric disorders, including dementia and epileptic seizures * Previous RT at the current irradiation site * Other severe disorders that in the judgment 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 or her consent.

What they're measuring

quality of life

Timeframe: 3-months-time-point after the end of RT

Trial details

NCT IDNCT02832830

SponsorHeidelberg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01

Contact for this trial

Harald Rief, MD, PhD

harald.rief@med.uni-heidelberg.de