NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedGastric cancer
Date of first enrollment2007/05/01
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy and surgery

Outcome(s)

Primary OutcomeResponse rate, pathological response
Secondary OutcomeOver all survival , relapse free survival, curative resection rate, operative complication rate, adverse event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaExclusion 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

Contact

public contact
Name Makoto Kinouchi
Address 1-1 Seiryo machi, Aoba-ku, Miyagi, Japan Japan
Telephone 022-717-7205
E-mail 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
E-mail
Affiliation Tohoku University, Graduate School of Medicine Division of Biological Regulation and Oncology, Department of Surgery