title: Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.
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 %).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, 3010, Bern, Switzerland. nikola.cihoric@gmail.com.
authors.forename: Nikola
authors.identifier: http://orcid.org/0000-0003-1534-8520
authors.initials: N
authors.lastname: Cihoric
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, 3010, Bern, Switzerland.
authors.forename: Alexandros
authors.initials: A
authors.lastname: Tsikkinis
authors.affiliation: Department of BT, ICO Hospitalet, Hospital Duran iReynals, l'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Cristina Gutierrez
authors.initials: CG
authors.lastname: Miguelez
authors.affiliation: Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
authors.forename: Vratislav
authors.initials: V
authors.lastname: Strnad
authors.affiliation: Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Ivan
authors.initials: I
authors.lastname: Soldatovic
authors.affiliation: Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Pirus
authors.initials: P
authors.lastname: Ghadjar
authors.affiliation: Institute of Lung Diseases, Sremska Kamenica, Serbia.|Centre for Biomedical Research, BioIRC, Kragujevac, Serbia.
authors.forename: Branislav
authors.initials: B
authors.lastname: Jeremic
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, 3010, Bern, Switzerland.
authors.forename: Alan
authors.initials: A
authors.lastname: Dal Pra
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, 3010, Bern, Switzerland.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Aebersold
authors.affiliation: Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern, 3010, Bern, Switzerland.
authors.forename: Kristina
authors.initials: K
authors.lastname: Lössl
mesh_terms: D001918:Brachytherapy / Q000379:methods*; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D016889:Endometrial Neoplasms / Q000532:radiotherapy; D004938:Esophageal Neoplasms / Q000532:radiotherapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000532:radiotherapy*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy; D011879:Radiotherapy Dosage; D002583:Uterine Cervical Neoplasms / Q000532:radiotherapy
keywords: Brachytherapy; Clinicaltrials.gov; Interventional clinical trials