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Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized…

Overview of attention for article published in BMC Cancer, November 2016
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Title
Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design
Published in
BMC Cancer, November 2016
DOI 10.1186/s12885-016-2947-0
Pubmed ID
Authors

Joanne M. van der Velden, Helena M. Verkooijen, Enrica Seravalli, Jochem Hes, A. Sophie Gerlich, Nicolien Kasperts, Wietse S. C. Eppinga, Jorrit-Jan Verlaan, Marco van Vulpen

Abstract

Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the 'cohort multiple Randomized Controlled Trial' design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized Controlled Trial design. This design addresses common difficulties associated with classic pragmatic randomized controlled trials, such as disappointment bias in patients allocated to the control arm, slow recruitment, and poor generalizability. The Netherlands Trials Register number NL49316.041.14. ClinicalTrials.gov registration number NCT02364115 . Date of trial registration February 1, 2015.

Twitter Demographics

The data shown below were collected from the profile of 1 tweeter who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 77 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 77 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 11 14%
Student > Master 9 12%
Researcher 9 12%
Student > Ph. D. Student 9 12%
Other 6 8%
Other 9 12%
Unknown 24 31%
Readers by discipline Count As %
Medicine and Dentistry 33 43%
Nursing and Health Professions 5 6%
Pharmacology, Toxicology and Pharmaceutical Science 3 4%
Business, Management and Accounting 1 1%
Agricultural and Biological Sciences 1 1%
Other 3 4%
Unknown 31 40%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 28 September 2017.
All research outputs
#11,912,644
of 13,436,295 outputs
Outputs from BMC Cancer
#4,106
of 5,051 outputs
Outputs of similar age
#308,388
of 376,458 outputs
Outputs of similar age from BMC Cancer
#454
of 645 outputs
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