Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases
IRON-2
1 other identifier
interventional
120
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJuly 14, 2016
July 1, 2016
1.4 years
July 12, 2016
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
local control
local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
3 months after RT
Secondary Outcomes (4)
progression-free survival (PFS)
2 years post completion of radiotherapy
pain reduction
end of treatment, 12 and 24 weeks post completion of radiotherapy
Quality of life
12 and 24 weeks post completion of therapy
Fatigue
12 and 24 weeks post completion of therapy
Study Arms (4)
A
EXPERIMENTALIntensity modulated radiotherapy (IMRT) 30Gy in 10 fractions
B
EXPERIMENTALIntensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis
C
EXPERIMENTALIntensity modulated radiotherapy (IMRT) 20Gy in 5 fractions
D
EXPERIMENTALIntensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis
Interventions
Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases
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
Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, 69120, Germany
Related Publications (5)
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.
PMID: 24890347RESULTGuckenberger 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.
PMID: 22172095RESULTKatsoulakis 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.
PMID: 23101946RESULTChung 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.
PMID: 23052695RESULTSprave 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.
PMID: 29357902DERIVED
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2016
First Posted
July 14, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
July 14, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share