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

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

doi:10.1186/s13014-016-0624-8

Abstract

BackgroundTo evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures.MethodsThe 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.ResultsIn 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 %).ConclusionMost 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users.

Highlights

Radiotherapy (RT) was first applied in medicine at the beginning of the 20th century [1]
Focused on the protocol initiator, academy is dominant in the BF group but equal with National Institute of Health USA (NIH) in the OT group
No significant differences were seen between all trials, BF and OT groups according to the countries where the trials were conducted (p: 0.355) (Table 1)

Summary

Introduction

Radiotherapy (RT) was first applied in medicine at the beginning of the 20th century [1]. Brachytherapy (BT) has been a well-established modality, mainly due to its high conformity and possibility of sparing organs-at-risk [3]. The field of RT has recently seen the Several clinical trial registries were established during the past decade. Trial registration is being regulated with European and US federal laws as well as international conventions (World Health Organization, WHO) [5, 6]. Registration of all interventional clinical trials is obligatory in the European Union (EU) and the United States (US) and is demanded by an international consortium of medical journal editors [7, 8]. ClinicalTrials.gov is the largest clinical trial registry with over 190,000 registered trials and a high weekly growth rate of new registrations. To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures

Results

Discussion

Conclusion