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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis
external beam Radiotherapy of the involved spinal bone metastasis
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, Germany
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).
Time frame: 3-months-time-point after the end of RT
bone density
bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
Time frame: 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
Time frame: end of treatment, 12 and 24 weeks post completion of radiotherapy
Fatigue
Fatigue is assessed using the EORTC FA13 questionnaire
Time frame: 12 and 24 weeks post completion of therapy
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