Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases — IRON-1  

Vertebral Bony Metastases Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Vertebral Bony Metastases

• NCT number: NCT02832830
• Study type: Interventional
• Source: Heidelberg University
• Contact: Harald Rief, MD, PhD
• Email: harald.rief@med.uni-heidelberg.de
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2016
• Completion date: January 2020