Unique ID issued by UMIN | UMIN000010057 |
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Receipt number | R000011711 |
Scientific Title | Phase II study of taxan for refractory esophageal cancer "KTT01" |
Date of disclosure of the study information | 2013/02/17 |
Last modified on | 2018/10/23 08:31:25 |
Phase II study of taxan for refractory esophageal cancer "KTT01"
KTT01
Phase II study of taxan for refractory esophageal cancer "KTT01"
KTT01
Japan |
esophageal cancer
Gastroenterology | Hematology and clinical oncology |
Malignancy
NO
Anti tumor effect (overall survival) and safety
Safety,Efficacy
Exploratory
Pragmatic
Phase II
overall survival
response rate, disease control rate, progression free survival, toxicity, QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Weekly paclitaxel for docetaxel-resistant case.
Docetaxel for paclitaxel-resistant case.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histological proven esophageal cancer (excluding small cell carcinoma and neuroendocrine carcinoma)
2) Measurable lesions not required
3) Following previous treatment
Intolerant or refractory to 5FU and cisplatin.
Refractory to paclitaxel or docetaxel.
4) Age>20 or older
5) ECOG performance status 0-2
6) Adequate interval from previous treatments
7) Adequate organ function
8) Expected >8 weeks survival
9) Written informed consent from patient
Symptomatic brain metastasis
Paralytic or mechanical bowel obstruction
Confirmed or suspected infection
Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous)
Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure)
Pregnant or possibly pregnant, and nursing women
Sever neurologic disease
Other conditions not suitable for this study
20
1st name | |
Middle name | |
Last name | Ura Takashi |
Aichi Cancer Center Hospital
Department of Clinical Oncology
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
052-762-6111
tura@aichi-cc.jp
1st name | |
Middle name | |
Last name | Ura Takashi |
Aichi Cancer Center Hospital
Department of Clinical Oncology
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
052-762-6111
tura@aichi-cc.jp
Aichi Cancer Center Hospital
Aichi Cancer Center Hospital
Other
NO
2013 | Year | 02 | Month | 17 | Day |
Unpublished
Completed
2013 | Year | 01 | Month | 12 | Day |
2013 | Year | 02 | Month | 07 | Day |
2013 | Year | 02 | Month | 17 | Day |
2018 | Year | 10 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011711
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