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Published in: Radiation Oncology 1/2016

Open Access 01-12-2016 | Research

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

Authors: Nikola Cihoric, Alexandros Tsikkinis, Cristina Gutierrez Miguelez, Vratislav Strnad, Ivan Soldatovic, Pirus Ghadjar, Branislav Jeremic, Alan Dal Pra, Daniel M. Aebersold, Kristina Lössl

Published in: Radiation Oncology | Issue 1/2016

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Abstract

Background

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures.

Methods

The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database.

Results

In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %).

Conclusion

Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.
Appendix
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Metadata
Title
Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database
Authors
Nikola Cihoric
Alexandros Tsikkinis
Cristina Gutierrez Miguelez
Vratislav Strnad
Ivan Soldatovic
Pirus Ghadjar
Branislav Jeremic
Alan Dal Pra
Daniel M. Aebersold
Kristina Lössl
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Radiation Oncology / Issue 1/2016
Electronic ISSN: 1748-717X
DOI
https://doi.org/10.1186/s13014-016-0624-8

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