DOS study

JRCT ID: jRCTs061180095

Registered date:22/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 10/01/2015
• Target sample size: 30
• Study type: Interventional
• 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 Outcome: maximum tolerated dose(MTD), Dose-limiting toxicities (DLTs), Recommended dose (RD), Response rate (RR)
• 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 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 criteria

1)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

• Primary Sponsor: Takayama Tetsuji