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)

BMC Cancer

Study Protocol

Akira Yoshida¹  Hisato Hara²  Iwao Sugitani³  Ken-ichi Ito⁴  Naoyoshi Onoda⁵  Shinichi Suzuki⁶  Kazuhisa Toda⁷  Kiminori Sugino⁸  Makoto Kammori⁹  Takuya Higashiyama^1,10  Akira Miyauchi^1,10 

[1] 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, 113-8603, Bunkyo-ku, Tokyo, Japan;Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, 241-8515, Asahi-ku, Yokohama-shi, Kanagawa, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Department of Breast and Endocrine Surgery, Tsukuba University, 1-1-1 Tenno-dai, 305-0006, Tsukuba-shi, Ibaragi, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Department of Endocrine Surgery, Nippon Medical School, 1-1-5 Sendagi, 113-8603, Bunkyo-ku, Tokyo, Japan;Division of Head and Neck, Cancer Institute Hospital, 3-8-31 Ariake, 135-8550, Koto-ku, Tokyo, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Department of Surgery II, Shinshu University, 3-1-1 Asahi, 390-8621, Matsumoto-shi, Nagano, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, 545-8585, Osaka, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Department of Thyroid and Endocrinology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, 960-1295, Fukushima, Fukushima, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Division of Head and Neck, Cancer Institute Hospital, 3-8-31 Ariake, 135-8550, Koto-ku, Tokyo, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Ito Hospital, 4-3-6 Jingu-mae, Shibuya-ku, 150-8308, Tokyo, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Kanaji Hospital, 1-5-6 Nakazato, Kita-ku, 114-0015, Tokyo, Japan;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, 113-8603, Bunkyo-ku, Tokyo, Japan;Kuma Hospital, 8-2-35 Shimoyamate-dori, 650-0011, Chuo-ku, Kobe-shi, Hyogo, Japan;

关键词: Anaplastic thyroid cancer;    Chemotherapy;    Prospective study;    Feasibility;    Protocol;    Paclitaxel;   

DOI  :  10.1186/s12885-015-1490-8

 received in 2014-04-24, accepted in 2015-06-15,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundAnaplastic 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.DesignIn 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.DiscussionImportant 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.

【 授权许可】

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© Onoda et al. 2015