NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180096

Registered date:22/03/2019

Phase II study of DCS-T

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedgastric cancer
Date of first enrollment12/03/2019
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Docetaxel (50mg/m2) and CDDP (60mg/m2), S-1 (80mg/m2) and trastuzumab (6mg/kg) given on day 8, and S-1 (80mg/m2) given on days 1-14, repeated every three weeks.

Outcome(s)

Primary OutcomeResponse rate
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 positive by IHC or FISH method 4)Unresectable gastric cancer. 5)To have measurable lesions. 6)No prior chemotherapy or no influence of prior therapy. 7)Tolerable function of bone marrow, liver and kidney. 8)LVEF more than 50% 9)PS 0 - 1. 10)Expected survival for 3 months. 11)Possible oral intake.
Exclude criteria1)History of hypersensitivity to DCS. 2)Contraindication to TXT, CDDP, S-1, G-CSF. 3)Infectious disease. 4)Severe compliaction. 5)Brain metastasis with clinical symptoms. 6)Watery diarea. 7)Active double cancer. 8)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