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

Heidelberg University1 site in 1 country60 target enrollmentAugust 2016

Overview

Brief 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

Detailed Description

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 After the baseline measurements have been recorded, the patients will be randomly assigned to one of the two groups: IMRT 10×3 Gy (n = 30) or fractionated conventional 3D-RT 10×3 Gy (n = 30). The RT will be applied daily (mondy to Friday). Follow-up per patient: The target parameters will be measured and recorded at baseline, at the end of RT (t1), and at 12 weeks (t2) and 6 months (t3) after the end of the irradiation period.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

January 2020

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Heidelberg University

Responsible Party

Sponsor

Eligibility Criteria

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

•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.

Outcomes

Primary Outcomes

quality of life

Time Frame: 3-months-time-point after the end of RT

improvement of more than 10% according to the EORTC BM22 questionaire measured at the 3-months-time-point after the end of RT (t2).

Secondary Outcomes

bone density(12 weeks post completion radiotherapy)
pain reduction(end of treatment, 12 and 24 weeks post completion of radiotherapy)
Fatigue(12 and 24 weeks post completion of therapy)