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

NCT02832830 | Unknown Phase 2

• 1 other identifier: IRON-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Vertebral Bony Metastases

Keywords

bony metastases; palliative radiotherapy

Outcome Measures

Primary Outcomes (1)

• quality of life

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

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

Secondary Outcomes (3)

• 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

Study Arms (2)

A

EXPERIMENTAL

intensity modulated radiotherapy (IMRT) 10 x 3 Gy

Radiation: IMRT

B

ACTIVE COMPARATOR

fractionated conventional external beam RT 10×3 Gy

Radiation: fractionated RT

Interventions

IMRT RADIATION

Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis

A

fractionated RT RADIATION

external beam Radiotherapy of the involved spinal bone metastasis

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Dept of Radiation Oncology, University of Heidelberg, Germany

Heidelberg, Germany, 69120, Germany

Location

Related Publications (6)

• Chung Y, Yoon HI, Kim JH, Nam KC, Koom WS. Is helical tomotherapy accurate and safe enough for spine stereotactic body radiotherapy? J Cancer Res Clin Oncol. 2013 Feb;139(2):243-8. doi: 10.1007/s00432-012-1321-0. Epub 2012 Oct 2.

  PMID: 23052695 RESULT

• Katsoulakis E, Riaz N, Cox B, Mechalakos J, Zatcky J, Bilsky M, Yamada Y. Delivering a third course of radiation to spine metastases using image-guided, intensity-modulated radiation therapy. J Neurosurg Spine. 2013 Jan;18(1):63-8. doi: 10.3171/2012.9.SPINE12433. Epub 2012 Oct 26.

  PMID: 23101946 RESULT

• Murai T, Murata R, Manabe Y, Sugie C, Tamura T, Ito H, Miyoshi Y, Shibamoto Y. Intensity modulated stereotactic body radiation therapy for single or multiple vertebral metastases with spinal cord compression. Pract Radiat Oncol. 2014 Nov-Dec;4(6):e231-7. doi: 10.1016/j.prro.2014.02.005. Epub 2014 Mar 31.

  PMID: 25407874 RESULT

• Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.

  PMID: 12573746 RESULT

• Sprave T, Verma V, Forster R, Schlampp I, Hees K, Bruckner T, Bostel T, El Shafie RA, Welzel T, Nicolay NH, Debus J, Rief H. Bone density and pain response following intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for vertebral metastases - secondary results of a randomized trial. Radiat Oncol. 2018 Oct 30;13(1):212. doi: 10.1186/s13014-018-1161-4.

  PMID: 30376859 DERIVED

• Meyerhof E, Sprave T, Welte SE, Nicolay NH, Forster R, Bostel T, Bruckner T, Schlampp I, Debus J, Rief H. Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial. Trials. 2017 Mar 3;18(1):98. doi: 10.1186/s13063-017-1847-1.

  PMID: 28253920 DERIVED

Central Study Contacts

Harald Rief, MD, PhD

CONTACT

harald.rief@med.uni-heidelberg.de

Jürgen Debus, MD, PhD

CONTACT

juergen.debus@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: July 14, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)