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)

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 

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Veröffentlicht in:BMC cancer 2015-06, Vol.15 (1), p.475-475, Article 475
Hauptverfasser: Onoda, Naoyoshi, Sugitani, Iwao, Higashiyama, Takuya, Hara, Hisato, Ito, Ken-ichi, Kammori, Makoto, Sugino, Kiminori, Suzuki, Shinichi, Toda, Kazuhisa, Yoshida, Akira, Miyauchi, Akira
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container_title BMC cancer
container_volume 15
creator Onoda, Naoyoshi
Sugitani, Iwao
Higashiyama, Takuya
Hara, Hisato
Ito, Ken-ichi
Kammori, Makoto
Sugino, Kiminori
Suzuki, Shinichi
Toda, Kazuhisa
Yoshida, Akira
Miyauchi, Akira
description 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 
doi_str_mv 10.1186/s12885-015-1490-8
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The median survival of ATC patients after initial diagnosis was reported to be &lt;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. 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. Important information concerning the management of this disease is expected to be revealed by this study. 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The median survival of ATC patients after initial diagnosis was reported to be &lt;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. 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. 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.</description><subject>Adult</subject><subject>Aged</subject><subject>Cancer</subject><subject>Care and treatment</subject><subject>Chemotherapy</subject><subject>Development and progression</subject><subject>Drug therapy</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Japan</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Paclitaxel - administration &amp; dosage</subject><subject>Prognosis</subject><subject>Study Protocol</subject><subject>Thyroid cancer</subject><subject>Thyroid Carcinoma, Anaplastic - drug therapy</subject><subject>Thyroid Carcinoma, Anaplastic - epidemiology</subject><subject>Thyroid Carcinoma, Anaplastic - pathology</subject><subject>Treatment Outcome</subject><issn>1471-2407</issn><issn>1471-2407</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkt9q2zAUxs3YWLtuD7CbIRiM9sKN5CiyfFMIYX86CitbBrsTsnQUa1Msz5Kb-tH2dpNJVxIYupCO9Ps-jg5flr0m-JIQzmaBFJwvckwWOaEVzvmT7JTQkuQFxeXTg_NJ9iKEnxiTkmP-PDspGK4Ip-w0-7PyrYIuItlqpCHYTYu8QRK1Mlrf7qwG1PU-dKCivQNkQAZbW2fjOANjrJJqnAVpII4oxEGPk3oH8MuNqJMqcfIeHDK-T2W00MaAdjY2U9V45zfJwSVW-dbYfgs6NSI7J0O0CsVm7L3VSMnUY4_Ol-vV6nN-u_6R3xYXL7NnRroArx72s-z7h_fr1af85svH69XyJlcMk5jXBKtSaVIzVtRQ6ooTXWDA85LqoqpqbTCbc1wBZnxe12VZlQstK0OkImoBan6WXe19u6FO_an0hV460fV2K_tReGnF8UtrG7Hxd4LSklJWJoPzB4Pe_x4gRLG1QYFzsgU_BEFYhRnlVUkS-naPbqQDYVvjk6OacLFcUEJx6pgl6vI_VFoatjYNEoxN90eCiyNBYiLcx40cQhDX374es-8O2Aaki03wbpjSEI5BsgdVikfowTyOhGAxxVPs4ylSPMUUT8GT5s3hLB8V__I4_wuVWeLA</recordid><startdate>20150620</startdate><enddate>20150620</enddate><creator>Onoda, Naoyoshi</creator><creator>Sugitani, Iwao</creator><creator>Higashiyama, Takuya</creator><creator>Hara, Hisato</creator><creator>Ito, Ken-ichi</creator><creator>Kammori, Makoto</creator><creator>Sugino, Kiminori</creator><creator>Suzuki, Shinichi</creator><creator>Toda, Kazuhisa</creator><creator>Yoshida, Akira</creator><creator>Miyauchi, Akira</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>ISR</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150620</creationdate><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)</title><author>Onoda, Naoyoshi ; Sugitani, Iwao ; Higashiyama, Takuya ; Hara, Hisato ; Ito, Ken-ichi ; Kammori, Makoto ; Sugino, Kiminori ; Suzuki, Shinichi ; Toda, Kazuhisa ; Yoshida, Akira ; Miyauchi, Akira</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c601t-b10c7cd1b662be7d981d20e0374d299bdf063809e0683bb77975da9f1ac1c5ec3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Cancer</topic><topic>Care and treatment</topic><topic>Chemotherapy</topic><topic>Development and progression</topic><topic>Drug therapy</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Japan</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Paclitaxel - administration &amp; dosage</topic><topic>Prognosis</topic><topic>Study Protocol</topic><topic>Thyroid cancer</topic><topic>Thyroid Carcinoma, Anaplastic - drug therapy</topic><topic>Thyroid Carcinoma, Anaplastic - epidemiology</topic><topic>Thyroid Carcinoma, Anaplastic - pathology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Onoda, Naoyoshi</creatorcontrib><creatorcontrib>Sugitani, Iwao</creatorcontrib><creatorcontrib>Higashiyama, Takuya</creatorcontrib><creatorcontrib>Hara, Hisato</creatorcontrib><creatorcontrib>Ito, Ken-ichi</creatorcontrib><creatorcontrib>Kammori, Makoto</creatorcontrib><creatorcontrib>Sugino, Kiminori</creatorcontrib><creatorcontrib>Suzuki, Shinichi</creatorcontrib><creatorcontrib>Toda, Kazuhisa</creatorcontrib><creatorcontrib>Yoshida, Akira</creatorcontrib><creatorcontrib>Miyauchi, Akira</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Science</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Onoda, Naoyoshi</au><au>Sugitani, Iwao</au><au>Higashiyama, Takuya</au><au>Hara, Hisato</au><au>Ito, Ken-ichi</au><au>Kammori, Makoto</au><au>Sugino, Kiminori</au><au>Suzuki, Shinichi</au><au>Toda, Kazuhisa</au><au>Yoshida, Akira</au><au>Miyauchi, Akira</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>BMC cancer</jtitle><addtitle>BMC Cancer</addtitle><date>2015-06-20</date><risdate>2015</risdate><volume>15</volume><issue>1</issue><spage>475</spage><epage>475</epage><pages>475-475</pages><artnum>475</artnum><issn>1471-2407</issn><eissn>1471-2407</eissn><abstract>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 &lt;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. 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. 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.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>26091846</pmid><doi>10.1186/s12885-015-1490-8</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Cancer
Care and treatment
Chemotherapy
Development and progression
Drug therapy
Feasibility Studies
Female
Health aspects
Humans
Japan
Male
Middle Aged
Neoplasm Staging
Paclitaxel - administration & dosage
Prognosis
Study Protocol
Thyroid cancer
Thyroid Carcinoma, Anaplastic - drug therapy
Thyroid Carcinoma, Anaplastic - epidemiology
Thyroid Carcinoma, Anaplastic - pathology
Treatment Outcome
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)
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