Unique ID issued by UMIN | UMIN000014707 |
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Receipt number | R000017036 |
Scientific Title | Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial |
Date of disclosure of the study information | 2014/07/30 |
Last modified on | 2019/02/01 11:37:10 |
Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial
Neoadjuvant chemotherapy by S-1 plus cisplatin for esophageal squamous cell carcinoma
Efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma: A phase II trial
Neoadjuvant chemotherapy by S-1 plus cisplatin for esophageal squamous cell carcinoma
Japan |
Esophageal squamous cell carcinoma
Gastrointestinal surgery |
Malignancy
NO
Evaluation of efficacy and safety of neoadjuvant chemotherapy by S-1 plus cisplatin for Stage III esophageal squamous cell carcinoma
Safety,Efficacy
Exploratory
Phase II
Response rate
Adverse event, 2 year survival rate, Progression free survival, Relative dose intensity, Pathological response
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Neoadjuvant chemotherapy by S-1 plus cisplatin
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically confirmed esophageal squamous cell carcinoma
2) Clinical stage III according to the Japanese classification of esophageal cancer (10th edition)
3) Age between 20 and 75 at registration
4) Performance Status(ECOG) 0 or 1
5) No prior treatment of chemotherapy or radiation therapy against any other malignancies
6) Adequate organ function
7) Written informed consent from patient
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Uncontrolled infection
3) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
4) Psychiatric disease
5) Continuous systemic steroid therapy
6) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.)
7) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated
8) Symptomatic CNS metastasis
9) Interstitial lung disease or pulmonary fibrosis
10) Hypersensitivity for S-1 or cisplatin
11) Flucytosine, phenytoin, warfarin potassium or aminoglycoside antibiotic administration
12) Intestinal bleeding
13) Judged by physician inadequate for inclusion in this trial
30
1st name | |
Middle name | |
Last name | Masahiko Koike |
Nagoya University Graduate School of Medicine
Department of Gastroenterological Surgery
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-744-2249
dockoike@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Masahiko Koike |
Nagoya University Graduate School of Medicine
Department of Gastroenterological Surgery
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-744-2249
dockoike@med.nagoya-u.ac.jp
Nagoya University Hospital
None
Self funding
NO
2014 | Year | 07 | Month | 30 | Day |
Unpublished
Completed
2011 | Year | 04 | Month | 30 | Day |
2011 | Year | 07 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2014 | Year | 07 | Month | 30 | Day |
2019 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017036
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