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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | intensity modulated radiotherapy (IMRT) 10 x 3 Gy |
|
| B | Active Comparator | fractionated conventional external beam RT 10×3 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT | Radiation | Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| pain reduction | pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harald Rief, MD, PhD | Contact | harald.rief@med.uni-heidelberg.de | ||
| Jürgen Debus, MD, PhD | Contact | juergen.debus@med.uni-heidelberg.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Radiation Oncology, University of Heidelberg, Germany | Heidelberg | Germany | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23052695 | Result | 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. | |
| 23101946 | 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. |
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| fractionated RT |
| Radiation |
external beam Radiotherapy of the involved spinal bone metastasis |
|
| end of treatment, 12 and 24 weeks post completion of radiotherapy |
| Fatigue | Fatigue is assessed using the EORTC FA13 questionnaire | 12 and 24 weeks post completion of therapy |
| 25407874 | 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. |
| 12573746 | 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. |
| 30376859 | Derived | 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. |
| 28253920 | 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. |