title: 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).
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. nonoda@med.osaka-cu.ac.jp.|Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. nonoda@med.osaka-cu.ac.jp.
authors.forename: Naoyoshi
authors.initials: N
authors.lastname: Onoda
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. isugitani@nms.ac.jp.|Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. isugitani@nms.ac.jp.|Division of Head and Neck, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. isugitani@nms.ac.jp.
authors.forename: Iwao
authors.initials: I
authors.lastname: Sugitani
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. higashiyama@kuma-h.or.jp.|Kuma Hospital, 8-2-35 Shimoyamate-dori, Chuo-ku, Kobe-shi, Hyogo, 650-0011, Japan. higashiyama@kuma-h.or.jp.
authors.forename: Takuya
authors.initials: T
authors.lastname: Higashiyama
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. harahisa@md.tsukuba.ac.jp.|Department of Breast and Endocrine Surgery, Tsukuba University, 1-1-1 Tenno-dai, Tsukuba-shi, Ibaragi, 305-0006, Japan. harahisa@md.tsukuba.ac.jp.
authors.forename: Hisato
authors.initials: H
authors.lastname: Hara
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. kenito@shinshu-u.ac.jp.|Department of Surgery II, Shinshu University, 3-1-1 Asahi, Matsumoto-shi, Nagano, 390-8621, Japan. kenito@shinshu-u.ac.jp.
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Ito
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. kammori@kanaji.jp.|Kanaji Hospital, 1-5-6 Nakazato, Kita-ku, Tokyo, 114-0015, Japan. kammori@kanaji.jp.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kammori
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. k-sugino@ito-hospital.jp.|Ito Hospital, 4-3-6 Jingu-mae, Shibuya-ku, Tokyo, 150-8308, Japan. k-sugino@ito-hospital.jp.
authors.forename: Kiminori
authors.initials: K
authors.lastname: Sugino
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. shsuzuki@fmu.ac.jp.|Department of Thyroid and Endocrinology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, Fukushima, 960-1295, Japan. shsuzuki@fmu.ac.jp.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Suzuki
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. kazuhisa.toda@jfcr.or.jp.|Division of Head and Neck, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. kazuhisa.toda@jfcr.or.jp.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Toda
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. ayoshida@kcch.jp.|Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, 241-8515, Japan. ayoshida@kcch.jp.
authors.forename: Akira
authors.initials: A
authors.lastname: Yoshida
authors.affiliation: Prospective Clinical Study Committee of Anaplastic Thyroid Carcinoma Research Consortium of Japan, Headquarter in the Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. miyauchi@kuma-h.or.jp.|Kuma Hospital, 8-2-35 Shimoyamate-dori, Chuo-ku, Kobe-shi, Hyogo, 650-0011, Japan. miyauchi@kuma-h.or.jp.
authors.forename: Akira
authors.initials: A
authors.lastname: Miyauchi
mesh_terms: D000328:Adult; D000368:Aged; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D011379:Prognosis; D065646:Thyroid Carcinoma, Anaplastic / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel