UMIN ID: UMIN000001777
Registered date:16/03/2009
A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Gastric cancer |
Date of first enrollment | 2007/05/01 |
Target sample size | 25 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Chemotherapy and surgery |
Outcome(s)
Primary Outcome | Response rate, pathological response |
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Secondary Outcome | Over all survival , relapse free survival, curative resection rate, operative complication rate, adverse event |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | Exclusion criteria 1)Fresh bleeding from the tumor 2)Paralysis of intestine or ileus 3)Diarrhea(watery stool) 4) Synchronous multicancer 5) infection 6) Interstitial pneumonitis or fibroid lung 7) a large amount of pleural effusion or ascites 8) Jaundice 9)Uncontrollable diabetes mellitus, 10) heart failure requiring the treatment, myocardial infarction within 6 months, uncontrolled arrhythmia or angina 11)Patients pregnant or in lactation, or wish to become pregnant during this study. Male patients who intend to make someone pregnant during this study 12)Patient who has experienced serious drug allergy in the past 13)Patient who is judged to be inappropriate for this study by the principal investigator or the doctors in charge |
Related Information
Primary Sponsor | Division of Biological Regulation and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Division of Biological Regulation and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University |
Secondary ID(s) |
Contact
public contact | |
Name | Makoto Kinouchi |
Address | 1-1 Seiryo machi, Aoba-ku, Miyagi, Japan Japan |
Telephone | 022-717-7205 |
kinouchi@surg1.med.tohoku.ac.jp | |
Affiliation | Graduate School of Medicine, Tohoku University Division of Biological Regulation and Oncology, Department of Surgery |
scientific contact | |
Name | Iwao Sasaki |
Address | 1-1 Seiryo machi, Aoba-ku, Miyagi, Japan Japan |
Telephone | 022-717-7205 |
Affiliation | Tohoku University, Graduate School of Medicine Division of Biological Regulation and Oncology, Department of Surgery |