Unique ID issued by UMIN | UMIN000023736 |
---|---|
Receipt number | R000027338 |
Scientific Title | Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments |
Date of disclosure of the study information | 2016/08/26 |
Last modified on | 2018/08/26 15:50:54 |
Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Japan |
esophageal cancer
Gastroenterology |
Malignancy
NO
To explore the efficacy and the safety of S-1 therapy for esophageal cancer resistant or intolerable existing treatments
Safety,Efficacy
progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 treatment (day1-28)
20 | years-old | <= |
Not applicable |
Male and Female
1) advanced or recurrent esophageal cancer proven histologically
2) aged >= 20 years old
3) ECOG PS of 0, 1 or 2
4) resistant or intolerable existing treatments
5) adequate food intake
6) with measurable lesions
7) Adequate organ functions
8) Written informed consent
1) Previous treatment with S-1
2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure)
3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
4) History of severe allergic reactions to pyrimidine fluoride drug
5) Active infection
6) With severe diarrhea
7) With symptomatic metastasis to nerve
8) Psychosis
9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
11) Participant to other clinical trials
12) Any patients judged by the investigator to be unfit to participate in the study
50
1st name | |
Middle name | |
Last name | Tetsuo Takehara |
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-5111
takehara@gh.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshito Hayashi |
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-5111
y.hayashi@gh.med.osaka-u.ac.jp
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Self funding
NO
2016 | Year | 08 | Month | 26 | Day |
Unpublished
Terminated
2016 | Year | 08 | Month | 23 | Day |
2016 | Year | 08 | Month | 26 | Day |
2016 | Year | 08 | Month | 23 | Day |
2018 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027338