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Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases (IRON-1)

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ClinicalTrials.gov Identifier: NCT02832830
Recruitment Status : Not yet recruiting
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Heidelberg University

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


Condition or disease Intervention/treatment Phase
Vertebral Bony Metastases Radiation: IMRT Radiation: fractionated RT Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases
Study Start Date : August 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: A
intensity modulated radiotherapy (IMRT) 10 x 3 Gy
Radiation: IMRT
Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis

Active Comparator: B
fractionated conventional external beam RT 10×3 Gy
Radiation: fractionated RT
external beam Radiotherapy of the involved spinal bone metastasis




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Fatigue [ Time Frame: 12 and 24 weeks post completion of therapy ]
    Fatigue is assessed using the EORTC FA13 questionnaire



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832830


Contacts
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Contact: Harald Rief, MD, PhD harald.rief@med.uni-heidelberg.de
Contact: Jürgen Debus, MD, PhD juergen.debus@med.uni-heidelberg.de

Locations
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Germany
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT02832830     History of Changes
Other Study ID Numbers: IRON-1
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Heidelberg University:
bony metastases
palliative radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes