A randomized phase II trial of TSU-68 in patients with advanced gastric cancer
Phase 2
- Conditions
- Gastric cancer
- Registration Number
- JPRN-jRCT2080221290
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
1)Histologically or cytologically proven unresectable or recurrent gastric adenocarcinoma.
2)Target lesions confirmed by Imaging-based evaluation such as CT within 28 days before enrollment.
3)No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) for gastric cancer.
4)Adequate oral intake.
5)ECOG Performance Status of 0 to 1.
Exclusion Criteria
1)Contraindication to TS-1 or CDDP.
2)Severe complications.
3)Colon disorder with active inflammation.
4)History of severe thrombosis or embolism.
5)Active double cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival<br>RECIST v1.0
- Secondary Outcome Measures
Name Time Method Safety, Response rate, Pharmacokinetics, Overall survival<br>CTCAE v3.0