UnknownPhase 2

Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

Germany120 participantsStarted 2016-09

Plain-language summary

The primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and consecutively an increased re-sclerotization of the bone metastasis due to a higher biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain relief and mobility.

Who can participate

Age range18 Years – 80 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, with secondarily diagnosed solitary/multiple metastatic spinal bone metastases * Indication for RT of the bone metastasis * Age: between 18 and 80 years * Karnofsky performance score ≥ 70 * Signed Declaration of Informed Consent * Bisphosphonate therapy Exclusion Criteria: * Significant neurological or psychiatric disorders, including dementia and epileptic seizures * Lacking or diminished legal capacity * foregoing radiotherapy in the planned RT area * 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

What they're measuring

local control

Timeframe: 3 months after RT

Trial details

NCT IDNCT02832765

SponsorHeidelberg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02

Contact for this trial

Harald Rief, MD, PhD

harald.rief@med.uni-heidelberg.de