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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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


Detailed 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 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.


Sponsor: Heidelberg University

Current Primary Outcome: quality of life [ Time Frame: 3-months-time-point after the end of RT ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • bone density [ Time Frame: 12 weeks post completion radiotherapy ]
    bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
  • pain reduction [ Time Frame: end of treatment, 12 and 24 weeks post completion of radiotherapy ]
    pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation
  • Fatigue [ Time Frame: 12 and 24 weeks post completion of therapy ]
    Fatigue is assessed using the EORTC FA13 questionnaire


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: July 12, 2016
Date Started: August 2016
Date Completion: January 2020
Last Updated: July 12, 2016
Last Verified: July 2016