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Vertebral Bony MetastasesPhase 2IRON-2NCT02832765

Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

A Phase 2 study testing A, B and C 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 The sponsor has not verified this record for over two years, so it may be out of date.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 primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Vertebral Bony Metastases
What is being tested?
A, B and C
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGermany
Study dates
Sep 2016to Feb 2018
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a histologically confirmed tumor diagnosis, with secondarily diagnosed solitary/multiple metastatic spinal bone metastases
  • Indication for RT of the bone metastasis
  • Age: between 18 and 80 years
  • Karnofsky performance score ≥ 70
  • Signed Declaration of Informed Consent
  • Bisphosphonate therapy

Who cannot join

  • Significant neurological or psychiatric disorders, including dementia and epileptic seizures
  • Lacking or diminished legal capacity
  • foregoing radiotherapy in the planned RT area
  • 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/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 primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and consecutively an increased re-sclerotization of the bone metastasis due to a higher biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain relief and mobility.

Read the detailed description

The vertebral column is the main localization of bone metastases and is where they frequently indicate an advanced stage of a malignant primary disease [1, 2]. Two thirds of all patients with tumors are estimated to develop bone metastases in the course of their disease [3]. Spinal bone metastases are of central impact for patients in a palliative setting. The clinical symptoms include pain at rest and under exercise but also impaired activity of daily life, the risk of pathological fractures, and neurological deficits. Local control is the essential factor for stability of the vertebral body of patients with spinal bone metastases. In regard to re-calcification of former osteolytic lesions, palliative radiotherapy (RT) represents an effective treatment option [4]. The most common schedule was specified as 30 Gy in 10 fractions. Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal metastasis with enhanced targeting accuracy [5]. Secondly, IMRT to the spine was well tolerated (especially in the spinal cord), had no significant late toxicities, and spared other organs at risk simultaneously [6]. The main problem of the standard schedule is the limited dose application to the metastasis due to organ at risk myelon. Therefore, the aims of this study is to apply a high biological dose in the tumor region and to achieve an improved result related to local control for palliative patients with painful spinal bone metastases. Secondly, the aim is to evaluate QoL, fatigue, and survival of three different RT-techniques. To the best of our knowledge, no comparable randomized study has been described in the literature so far.

Being tested
A, B, C, D
Keywords
Palliative radiotherapy, Bone metastases

What participants receive

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

  • ARadiation

    Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases

  • BRadiation

    Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis of the involved spinal bone metastases

  • CRadiation

    Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases

  • DRadiation

    Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis of the involved spinal bone metastases

Study groups in NCT02832765
Study groupRoleWhat they receive
AExperimentalIntensity modulated radiotherapy (IMRT) 30Gy in 10 fractions
Receives: Radiation: A
BExperimentalIntensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis
Receives: Radiation: B
CExperimentalIntensity modulated radiotherapy (IMRT) 20Gy in 5 fractions
Receives: Radiation: C
DExperimentalIntensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis
Receives: Radiation: D

What is being measured

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

  1. local control

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

    Measured: 3 months after RT

Secondary outcomes (4)

  1. progression-free survival (PFS)

    PFS is assessed 2 years post completion of radiotherapy

    Measured: 2 years post completion of 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. Quality of life

    Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment

    Measured: 12 and 24 weeks post completion of therapy

  4. 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 startSep 2016
  3. Primary completionFeb 2018 (estimated)
  4. Study completionFeb 2018 (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
Factorial
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832765
Sponsor's protocol ID
IRON-2
Acronym
IRON-2
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

  • Ryu S, Pugh SL, Gerszten PC, Yin FF, Timmerman RD, Hitchcock YJ, Movsas B, Kanner AA, Berk LB, Followill DS, Kachnic LA. RTOG 0631 phase 2/3 study of image guided stereotactic radiosurgery for localized (1-3) spine metastases: phase 2 results. Pract Radiat Oncol. 2014 Mar-Apr;4(2):76-81. doi: 10.1016/j.prro.2013.05.001. Epub 2013 Jun 4.

    PubMed 24890347

  • Guckenberger M, Sweeney RA, Flickinger JC, Gerszten PC, Kersh R, Sheehan J, Sahgal A. Clinical practice of image-guided spine radiosurgery--results from an international research consortium. Radiat Oncol. 2011 Dec 15;6:172. doi: 10.1186/1748-717X-6-172.

    PubMed 22172095

  • 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

  • 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

  • Sprave T, Welte SE, Bruckner T, Forster R, Bostel T, Schlampp I, Nicolay NH, Debus J, Rief H. Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial. Trials. 2018 Jan 22;19(1):59. doi: 10.1186/s13063-018-2452-7.

    PubMed 29357902

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A, B and C 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 6 inclusion and 4 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?

local control (time frame: 3 months after 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 NCT02832765, which also lists 5 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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