Published in:
Open Access
01-12-2015 | Study protocol
Concept and design of a nationwide prospective feasibility/efficacy/safety study of weekly paclitaxel for patients with pathologically confirmed anaplastic thyroid cancer (ATCCJ-PTX-P2)
Authors:
Naoyoshi Onoda, Iwao Sugitani, Takuya Higashiyama, Hisato Hara, Ken-ichi Ito, Makoto Kammori, Kiminori Sugino, Shinichi Suzuki, Kazuhisa Toda, Akira Yoshida, Akira Miyauchi
Published in:
BMC Cancer
|
Issue 1/2015
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Abstract
Background
Anaplastic thyroid cancer (ATC) is one of the most aggressive malignancies in humans, often demonstrating resistance to multimodal therapeutic approaches. The median survival of ATC patients after initial diagnosis was reported to be < 6 months due to the rapid progression of disease by dissemination and/or invasion. There have been several reports describing possible effective chemotherapies, but these studies might be biased by the nature of retrospective accumulations of clinical experiences, and thus reliable data concerning the efficacies of the treatment efforts are required.
Design
In 2009, we established the research organization Anaplastic Carcinoma Research Consortium Japan (ATCCJ) to investigate this highly malignant disease. Using this nationwide organization, we conducted a prospective clinical study to investigate the feasibility, safeness, and efficacy of chemotherapy with weekly paclitaxel for ATC patients. This trial is registered on the clinical trials site of the University Hospital Medical Information Network Clinical Trials Registry Web site (UMIN000008574). The study was started in 2012, and enrollment was closed in March 2014 after accumulating 71 patients from 28 registered institutes. The follow-up data will be available in April 2015.
Discussion
Important information concerning the management of this disease is expected to be revealed by this study. The concept and design of the study are described herein.