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Vertebral Bony MetastasesPhase 2IRON-1NCT02832830

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

A Phase 2 study testing IMRT and fractionated RT in people with Vertebral Bony Metastases, run by Heidelberg University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Vertebral Bony Metastases
What is being tested?
IMRT and fractionated RT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGermany
Study dates
Aug 2016to Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Harald Rief, MD, PhD contact

harald.rief@med.uni-heidelberg.de

Jürgen Debus, MD, PhD contact

juergen.debus@med.uni-heidelberg.de

Germany1 site

  • Dept of Radiation Oncology, University of Heidelberg, Germany

    Heidelberg, Germany, 69120

Other trials in Germany

About this study

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:

Read more

IMRT 10 x 3 Gy

Control intervention:

3D-RT 10 x 3 Gy

Read the 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.

Being tested
IMRT, fractionated RT
Keywords
bony metastases, palliative radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMRTRadiation

    Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis

  • fractionated RTRadiation

    external beam Radiotherapy of the involved spinal bone metastasis

Study groups in NCT02832830
Study groupRoleWhat they receive
AExperimentalintensity modulated radiotherapy (IMRT) 10 x 3 Gy
Receives: Radiation: IMRT
BActive comparatorfractionated conventional external beam RT 10×3 Gy
Receives: Radiation: fractionated RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3-months-time-point after the end of RT

Secondary outcomes (3)

  1. bone density

    bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine

    Measured: 12 weeks post completion radiotherapy

  2. pain reduction

    pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation

    Measured: end of treatment, 12 and 24 weeks post completion of radiotherapy

  3. Fatigue

    Fatigue is assessed using the EORTC FA13 questionnaire

    Measured: 12 and 24 weeks post completion of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832830
Sponsor's protocol ID
IRON-1
Acronym
IRON-1
Status last verified
Jul 2016
First submitted
12 Jul 2016
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23052695

  • 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.

    PubMed 23101946

  • 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.

    PubMed 25407874

  • 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.

    PubMed 12573746

  • 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.

    PubMed 30376859

  • 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.

    PubMed 28253920

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMRT and fractionated RT in people with Vertebral Bony Metastases, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Harald Rief, MD, PhD (harald.rief@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quality of life (time frame: 3-months-time-point after the end of RT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832830, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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