Phase II study of DCS-T

JRCT ID: jRCTs061180096

Registered date:22/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 12/03/2019
• Target sample size: 30
• Study type: Interventional
• 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 Outcome: Response rate
• Secondary Outcome: median survival time (OS), progression-free survival(PFS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1)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 criteria

1)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

• Primary Sponsor: Takayama Tetsuji