Unique ID issued by UMIN | UMIN000020204 |
---|---|
Receipt number | R000022996 |
Scientific Title | Phase II trial of perioperative chemotherapy for esophageal cancer |
Date of disclosure of the study information | 2015/12/15 |
Last modified on | 2022/12/19 10:30:10 |
Phase II trial of perioperative chemotherapy for esophageal cancer
Phase II trial of perioperative chemotherapy for esophageal cancer
Phase II trial of perioperative chemotherapy for esophageal cancer
Phase II trial of perioperative chemotherapy for esophageal cancer
Japan |
esophageal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
Safety, Efficacy
Safety,Efficacy
Exploratory
Phase II
Three-year relapse free survival
Overall survival, time to treatment free survival, treatment completion rate, incidence of adverse events, incidence of treatment related death
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
S-1 80mg/m2/day is administered orally between day 1 and day 28. It takes 42 days for the one course. S-1 administration for 4 couses.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage IB-III(without T4 disease)
4) Aged 20 to 75 years old
5) ECOG PS of 0 or1
6) Performed neoadjuvant chemotherapy (5-FU+cisplatin)
7) No previous treatment of esophageal cancer except EMR or ESD
8) Adequate organ functions
9) Resectable disease (R0)
10) Written informed consent
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Positive HBs antigen, or positive HCV antibody.
4) Pregnancy, possible pregnancy or breastfeeding.
5) Psychiatric disease.
6) Patients who need flucitosine, fenitoin or warfarin.
7) Poorly controlled diabetes mellitus
8) Severe pulmonary fibrosis or emphysema.
9) Serious angina or myocaedial infarcion within 3 months
10) Patients whom principle/sub-investigator judged ineligible to participate in this study.
50
1st name | Manabu |
Middle name | |
Last name | Muto |
Kyoto university hospital
Department of Clinical Oncology
606-8507
54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
075-751-3111
mmuto@kuhp.kyoto-u.ac.jp
1st name | Motoo |
Middle name | |
Last name | Nomura |
Kyoto university hospital
Department of Clinical Oncology
606-8507
54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
075-751-3518
mnomura@kuhp.kyoto-u.ac.jp
Kyoto university hospital
TAIHO PHARMACEUTICAL CO.,LTD.
Profit organization
Medical research support company with limited liability
Kyoto university hospital
54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
075-751-3518
ethcom@kuhp.kyoto-u.ac.jp
NO
愛知県がんセンター中央病院、岩手医科大学、大分大学、大阪医科大学、鹿児島大学、神奈川県立病院機構神奈川県立がんセンター、がん研究会有明病院、京都大学、熊本大学、慶応義塾大学、高知医療センター、国立がん研究センター東病院、国立病院機構大阪医療センター、国立病院機構九州がんセンター、国立病院機構四国がんセンター、静岡県立静岡がんセンター、千葉大学、東海大学、東京医科歯科大学、東北大学、名古屋大学、新潟大学医歯学総合病院、兵庫県立がんセンター、広島市立安佐市民病院
2015 | Year | 12 | Month | 15 | Day |
Unpublished
Completed
2015 | Year | 11 | Month | 24 | Day |
2022 | Year | 07 | Month | 11 | Day |
2016 | Year | 01 | Month | 22 | Day |
2022 | Year | 01 | Month | 31 | Day |
2015 | Year | 12 | Month | 15 | Day |
2022 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022996
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