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

July 12, 2016 updated by: Heidelberg University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Dept of Radiation Oncology, University of Heidelberg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3-months-time-point after the end of RT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks post completion radiotherapy
Fatigue
Time Frame: 12 and 24 weeks post completion of therapy
Fatigue is assessed using the EORTC FA13 questionnaire
12 and 24 weeks post completion of therapy
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
end of treatment, 12 and 24 weeks post completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRON-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vertebral Bony Metastases

Clinical Trials on IMRT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe