NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180095

Registered date:22/03/2019

DOS study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedgastric cancer
Date of first enrollment10/01/2015
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Docetaxel (50mg/m2) and oxaliplatin (80-130mg/m2) given on day 8, and S-1 (80mg/m2) given on days 1-14, repeated every three weeks.

Outcome(s)

Primary Outcomemaximum tolerated dose(MTD), Dose-limiting toxicities (DLTs), Recommended dose (RD), Response rate (RR)
Secondary Outcomemedian survival time (OS), progression-free survival(PFS)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1)Written informed consent. 2)Histologicaly (cytologically) proven gastric cancer. 3)HER2 negative method 4)Unresectable gastric cancer. 5)To have evaluable lesions. 6)No prior chemotherapy or no influence of prior therapy. 7)Tolerable function of bone marrow, liver, and kidney. 8)PS 0 - 1. 9)Expected survival for three months. 10)Possible oral intake.
Exclude criteria1)History of hypersensitivity to DCS. 2)Contraindication to DTX, Oxaliplatin, S-1. 3)Infectious disease. 4)Severe complication. 5)Brain metastasis with clinical symptoms. 6)Watery diarrhea. 7)Active double cancer. 9)Persons to be pregnant or to make pregnant.

Related Information

Contact

Public contact
Name Yasushi Sato
Address 3-18-15, Kuramoto-cho, Tokushima city, 770-8503, Japan. Tokushima Japan 770-8503
Telephone +81-88-633-7124
E-mail sato.yasushi@tokushima-u.ac.jp
Affiliation Tokushima University
Scientific contact
Name Tetsuji Takayama
Address 3-18-15, Kuramoto-cho, Tokushima city, 770-8503, Japan. Tokushima Japan 770-8503
Telephone +81-88-633-7124
E-mail takayama@tokushima-u.ac.jp
Affiliation Tokushima University