Spots Global Cancer Trial Database for Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer
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Trial Identification
Brief Title: Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer
Official Title: Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer (HOPE)
Study ID: NCT02726503
Conditions
Interventions
Study Description
Brief Summary: The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of the study will be 30 months. All patients will start administration of lenvatinib within 1 week of enrollment and receive the study drug 24mg orally once daily at almost the same time. 1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug administration of cycle 1 and administration will be continued until patients meet withdrawal criteria. Safety and efficacy assesment will be conducted on a regular basis during the trial. Tumor evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks and at every 8 weeks after the 16th week since initial administration. When study drug administration terminated,tests of the drug termination will be conducted within 7 days of withdrawal and final observation will be conducted at 30 days after the last dose. Survival survey will be conducted at follow-up term. After the termination of the study drug, survival follow up survey will be conducted every 12 weeks unless patients withdraw enrollment of this study.
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Nagoya University Hospital, Nagoya-city, Aichi-prefecture, Japan
Fujita Health University Hospital, Toyoake-city, Aichi-prefecture, Japan
IUHW Ichikawa Hospital, Ichikawa-city, Chiba-prefecture, Japan
National Cancer Center Hospital East, Kashiwa-city, Chiba-prefecture, Japan
Japanese Red Cross Narita Hospital, Narita-city, Chiba-prefecture, Japan
Kuma Hospital, Kobe-city, Hyogo-prefecture, Japan
Kobe Univbersity Hospital, Kobe-city, Hyogo-prefecture, Japan
University of Tsukuba Hospital, Tsukuba-city, Ibaraki-prefecture, Japan
Iwate Medical University Hospital, Morioka-city, Iwate-prefecture, Japan
Kitasato University Hospital, Sagamihara-city, Kanagawa-prefecture, Japan
Showa University Northern Yokohama Hospital, Yokohama-city, Kanagawa-prefecture, Japan
Kanagawa Cancer Center, Yokohama-city, Kanagawa-prefecture, Japan
Miyaghi Cancer Center, Natori-city, Miyagi-prefecture, Japan
Tohoku University Hospital, Sendai-city, Miyagi-prefecture, Japan
Shinsyu University School of Medicine Department of Surgery, Matsumoto-city, Nagano-prefecture, Japan
Nara Hospital Kinki University Faculty of Medicine, Ikoma-city, Nara-prefecture, Japan
Nara Medical University, Kashihara-city, Nara-prefecture, Japan
Osaka Police Hospital, Osaka-city, Osaka-prefecture, Japan
Osaka City University Graduate School of Medicine and Faculty of Medicine, Osaka-city, Osaka-prefecture, Japan
Nippon Medical School Hospital, Bunkyo-ku, Tokyo-metropolis, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo-metropolis, Japan
Ito Hospital, Shibuya-ku, Tokyo-metropolis, Japan
Tokyo Medical University Hospital, Shinjuku-ku, Tokyo-metropolis, Japan
Contact Details
Name: Iwao Sugitani, M.D., Ph.D
Affiliation: Graduate School of Medicine Nippon Medical School
Role: STUDY_DIRECTOR
Name: Makoto Tahara, M.D., Ph.D
Affiliation: National Cancer Center Hospital East
Role: STUDY_DIRECTOR
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