Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Eva Meyerhof, Tanja Sprave, Stefan Ezechiel Welte, Nils H. Nicolay, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Jürgen Debus, Harald Rief

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Radiation therapy (RT) of bone metastases provides an important treatment approach in palliative care treatment concepts. As a consequence of treatment, the extent of radiation-induced toxicity is a crucial feature with consequences to a patient’s quality of life. In this context this study aims at reducing the extent of radiation-induced side effects and toxicity by assuming a better sparing of normal tissue with the use of intensity-modulated instead of conventionally delivered external beam radiotherapy.

Methods/design

In this prospective, randomized, single-center trial for patients with spinal bone metastases, RT is performed as either image-guided intensity-modulated radiotherapy (10x3Gy) or conventionally fractionated external beam radiotherapy (10x3Gy). Afterwards radiation-induced toxicity will be assessed and compared 3 and 6 months after the end of radiation.

Discussion

The aim of this pilot study is the evaluation of achievable benefits, with reduced radiation toxicity being the primary endpoint in the comparison of intensity-modulated radiotherapy versus conventional radiotherapy for patients with spinal bone metastases. Secondarily, bone re-calcification, quality of life, pain relief, spinal instability, and local control will be measured and compared between the two treatment groups.

Trial registration

ClinicalTrials.gov, NCT02832830. Registered on 12 July 2016.
Appendix
Available only for authorised users
Literature
1.
Wong DA, Fornasier VL, MacNab I. Spinal metastases: the obvious, the occult, and the impostors. Spine. 1990;15(1):1–4.CrossRefPubMed
2.
Bubendorf L, Schöpfer A, Wagner U, Sauter G, Moch H, Gasser TC, Mihatsch MJWN. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol. 2000;31(5):578–83.CrossRefPubMed
3.
Krempien B. Die Entstehung von Knochenschmerzen bei Knochenmetastasen und ihre Behandlung durch Bisphosphonate. In: Bartsch HH, Hornstein W, editors. Interdisziplinäre Schmerztherapie bei Tumorpatienten. Basel: Karger Publishers; 1998.
4.
Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006;12:6243s–9s.CrossRefPubMed
5.
Bostel T, Förster R, Schlampp I, Wolf R, Serras AF, Mayer A, Bruckner T, Welzel T, Schmidberger H, Debus J, Rief H. Stability, prognostic factors and survival of spinal bone metastases in malignant melanoma patients after palliative radiotherapy. Tumori. 2016;102(2):156–61.CrossRefPubMed
6.
Schlampp I, Lang H, Förster R, Wolf R, Bostel T, Bruckner T, Debus J, Rief H. Stability of spinal bone metastases and survival analysis in renal cancer after radiotherapy. Tumori. 2015;101(6):614–20.CrossRefPubMed
7.
Foerster R, Habermehl D, Bruckner T, Bostel T, Schlampp I, Welzel T, Debus J, Rief H. Spinal bone metastases in gynecologic malignancies: a retrospective analysis of stability, prognostic factors and survival. Radiat Oncol. 2014;9:194.CrossRefPubMedPubMedCentral
8.
Schlampp I, Rieken S, Habermehl D, Bruckner T, Förster R, Debus J, Rief H. Stability of spinal bone metastases in breast cancer after radiotherapy: a retrospective analysis of 157 cases. Strahlenther Onkol. 2014;190(9):792–7.CrossRefPubMedPubMedCentral
9.
Rief H, Muley T, Bruckner T, Welzel T, Rieken S, Bischof M, Lindel K, Combs SE, Debus J. Survival and prognostic factors in non-small cell lung cancer patients with spinal bone metastases: a retrospective analysis of 303 patients. Strahlenther Onkol. 2014;190(1):59–63.CrossRefPubMed
10.
Rief H, Heinhold M, Bruckner T, Schlampp I, Förster R, Welzel T, Bostel T, Debus J, Rieken S. German Bone Research Group. Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy—a prospective trial. Radiat Oncol. 2014;9:133.CrossRefPubMedPubMedCentral
11.
Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007;25(11):1423–36.CrossRefPubMed
12.
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 Ocol. 2013;139(2):243–8.CrossRef
13.
Sterzing F, Kalz J, Sroka-Perez G, Schubert K, Bischof M, Roder F, Debus J, Herfarth K. Megavoltage CT in helical tomotherapy — clinical advantages and limitations of special physical characteristics. Technol Cancer Res Treat. 2009;8(5):343–52.CrossRefPubMed
Metadata
Title
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
Authors
Eva Meyerhof
Tanja Sprave
Stefan Ezechiel Welte
Nils H. Nicolay
Robert Förster
Tilman Bostel
Thomas Bruckner
Ingmar Schlampp
Jürgen Debus
Harald Rief
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1847-1

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Does the use of the Informed Healthcare Choices (IHC) primary school resources improve the ability of grade-5 children in Uganda to assess the trustworthiness of claims about the effects of treatments: protocol for a cluster-randomised trial

Study protocol

A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial

Study protocol

Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial

Study protocol

Parenteral nutrition during neoadjuvant chemotherapy for patients with non-metastatic gastric or esophago-gastric cancer to reduce postoperative morbidity (PERCOG): study protocol for a randomized controlled trial

Study protocol

Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial

Research

Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity