Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov databaseReportar como inadecuado




Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Radiation Oncology

, 11:48

Clinical Radiation Oncology

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 indications, 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.

KeywordsBrachytherapy Clinicaltrials.gov Interventional clinical trials Abbreviations3Dthree dimensional

ADTandrogen deprivation therapy

APBIaccelerated partial breast irradiation

BCabreast cancer

BRFSbiochemical relapse-free survival

BTbrachytherapy

CCacervical cancer

CSScause-specific survival

DFSdisease free survival

EBRTexternal beam radiotherapy

ECaesophageal cancer

EUEuropean Union

GEC-ESTROGroupe Européen de Curiethérapie-European Society for radiotherapy and oncology

HDRhigh dose rate

IGBTimage guided brachytherapy

IMRTintensity-modulated radiation therapy

LDRlow dose rate

MRImagnetic resonance imaging

NSABPNational Surgical Adjuvant Breast and Bowel Project

PBIpartial breast irradiation

PCaprostate cancer

PETpositron emissions tomography

QOLquality of life

RTradiotherapy

SEERsurveillance, epidemiology, and end results program

USUnited States

VMATvolumetric modulated arc therapy

WBIwhole breast irradiation

Electronic supplementary materialThe online version of this article doi:10.1186-s13014-016-0624-8 contains supplementary material, which is available to authorized users.

Download fulltext PDF



Autor: Nikola Cihoric - Alexandros Tsikkinis - Cristina Gutierrez Miguelez - Vratislav Strnad - Ivan Soldatovic - Pirus Ghadjar -

Fuente: https://link.springer.com/







Documentos relacionados