Unique ID issued by UMIN | UMIN000020622 |
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Receipt number | R000023802 |
Scientific Title | Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy |
Date of disclosure of the study information | 2016/01/19 |
Last modified on | 2021/06/30 19:10:34 |
Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Japan |
esophageal cancer (stage0/IA)
Gastroenterology |
Malignancy
NO
To evaluate the endoscopic resectability by ESD for stage 0/IA esophageal cancer after DCF combination chemotherapy
Safety,Efficacy
Endoscopic resectability by ESD
Pathological curability, overall survival, progression free survival, safety of DCF chemotherapy, adverse events of ESD, the preservation rate of esophagus
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
Endoscopic submucosal dissection after DCF combination chemotherapy
20 | years-old | <= |
Not applicable |
Male and Female
1) Clinical stage 0/IA esophageal cancer according to UICC-TNM classification ver. 7
2) Extra indication of endoscopic treatment by circumference, size or depth
3) Aged >= 20 years old
4) ECOG PS 0 or 1
5) Possibility of oral intake
6) No previous history of treatment for esophageal cancer except non-invasive cancer
7) Adequate organ functions
8) Written informed consent
1) Previous treatment with pyrimidine fluoride, taxane, or platinum within 5 years
2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncotrollable diabetes mellitus or hypertention, history of myocardial infarction within 6 months, or unstable angina, liver cirrhosis, renal failure)
3) Simultaneous or metachronous cancers with the exception of cured malignancies with prior therapy
4) History of severe allergic reactions to pyrimidine fluoride drug, taxane, or platinum
5) Impossible discontuniation of anti thrombotic therapy
6) Active infection
7) Positive HBs antigen
8) Previous radiotherapy to chest
9) Continuous steroid administration
10) History of allergic reaction to iodine
11) Severe diarrhea
12) Psychosis
13) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
14) Patiets requiring the administration of flucytosine, phenytoin or warfarin potassium
15) Any patients judged by the investigator to be unfit to participate in the study
10
1st name | Tetsuo |
Middle name | |
Last name | Takehara |
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
565-0871
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-5111
takehara@gh.med.osaka-u.ac.jp
1st name | Yoshito |
Middle name | |
Last name | Hayashi |
Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
565-0871
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-5111
y.hayashi@gh.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
none
Self funding
Osaka University Clinical Research Review Committee
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
06-6879-5111
rinri@hp-crc.med.osaka-u.ac.jp
NO
2016 | Year | 01 | Month | 19 | Day |
Unpublished
No longer recruiting
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 01 | Month | 21 | Day |
2016 | Year | 01 | Month | 25 | Day |
2024 | Year | 12 | Month | 31 | Day |
2016 | Year | 01 | Month | 18 | Day |
2021 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023802
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