unresectable advanced or reccurent gastric cancer
Conditions
Interventions
Hematology tests, biochemistry tests, and assesment of symptoms and signs are carried out at the beginning of each treatment cycle. Physical examinations and laboratory studies will be added if needed
Sponsors
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients with unresectable advanced or recurrent gastric cancer, who are going to be treated with oral fluoropyrimidine plus oxaliplatin(i.e.,CapeOX or SOX) will be included. All patients older than 20 years of age are eligible if they have histologically confirmed inoperable locally advanced, recurrent, or metastatic HER-2 negative gastric cancer excluding the esophagus and gastroesophageal junction; Eastern Cooperative Oncology Group(ECOG) performance status 0-2; adequate organ fuction; able to take oral drugs. All patients provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients are excluded if they have HER-2 postive adenocarcinoma. HER-2 positivity is defined as IHC 3+ or IHC2+ and FISH-positive(HER2:CEP17 ratio over 2). Other exclusion criteria included uncontrolled infection, or uncontrolled significant comorbid conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| thrombocytopenia, anemia | — |
Secondary
| Measure | Time frame |
|---|---|
| neutropenia, sensory neuropathy, anorexia, diarrhea, and relative dose intensity(RDI) | — |
Countries
Japan
Contacts
Public ContactAyumu Matsuoka
Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed