DOS study
Phase 1
Recruiting
- Conditions
- gastric cancer
- Registration Number
- JPRN-jRCTs061180095
- Lead Sponsor
- Takayama Tetsuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion 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.
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method maximum tolerated dose(MTD), Dose-limiting toxicities (DLTs), Recommended dose (RD), Response rate (RR)
- Secondary Outcome Measures
Name Time Method median survival time (OS), progression-free survival(PFS)