unresectable advanced or recurrent gastric cancer
Conditions
Interventions
SOX Oxaliplatin/TS-1
Sponsors
Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric cancer (Adenocarcinoma) 2) Unresectable advanced/recurrent gastric cancer, HER2 Negative case 3) Aged over 20 years at the time of registration 4) Performance Status(ECOG):0 or 1 5) A measurable lesions in RECIST criteria is unnecessary 6) Previously not treated chemotherapy or radiotherapy for unresectable gastric cancer 7) Able to receive oral treatment 8) Adequate organ function 9) Life expectance estimated>=3 months 10) Written IC
Exclusion criteria
Exclusion criteria: 1) History of serious drug hypersensitivity 2) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant 3) Active infections 4 4) Serious complications 5) Serious heart disease 6) Peptic ulcers 7) Sensory neuropathy 8) Diarrhea 9) A case with abdominal dropsy and the hydrothorax to need waste fluid by the sustained drainage custody 10) Brain metastasis 11) Other active malignancies (Nondisease period less than 5 years) 12) Continuous steroid treatment 13) Any other cases who are regarded as inadequate for study enrollment by the investigator 14) Administration contraindication of L-OHP , TS-1 , 5-FU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part] progression-free survival (PFS) | — |
Countries
Japan
Contacts
Public ContactKyoichi Kaira
Gunma University Graduate School of Medicine Department of Oncology Clinical Development
Outcome results
None listed