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

Vertebral Bony Metastases Clinical Trial

— IRON-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02832830
• Other study ID #: IRON-1
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 12, 2016
• Last updated: July 12, 2016
• Start date: August 2016
• Est. completion date: January 2020

Study information

• Verified date: July 2016
• Source: Heidelberg University
• Contact: Harald Rief, MD, PhD
• Email: harald.rief[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: University of Heidelberg, Germany: Ethics committee
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

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

Intervention

Radiation:
• IMRT
Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis
• fractionated RT
external beam Radiotherapy of the involved spinal bone metastasis

Locations

Country	Name	City	State
Germany	Dept of Radiation Oncology, University of Heidelberg, Germany	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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.SPI — View Citation

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. — View Citation

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	bone density	bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine	12 weeks post completion radiotherapy	No
Secondary	pain reduction	pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation	end of treatment, 12 and 24 weeks post completion of radiotherapy	No
Secondary	Fatigue	Fatigue is assessed using the EORTC FA13 questionnaire	12 and 24 weeks post completion of therapy	No