Gastric cancer
Conditions
Interventions
Trastuzumab in combination with TS-1 and cisplatin
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proved adenocarcinoma of advanced gastric cancer and esophagogastric junction. 2) Patients without prior chemotherapy. i)In the patients with recurrence disease after curative tumor resection, adjuvant chemotherapy with fluoropyrimidine is permitted. ii)In the patients who received adjuvant chemotherapy with fluoropyrimidine, more than 6 months after completion of chemotherapy is necessary to enroll. 3) Patients who have HER2-positive cancer confirmed with IHC3+ or IHC2+/FISH >= 2.0. 4) ECOG performance status 0-2. 5) Patients with one or more measurable lesion as defined by the RECIST criteria. 6) Patients who can intake orally. 7) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 9.0 g/dL, platelet count >= 100,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 1.5 mg/dL), kidney function (serum creatinine <=1.2 mg/dL, creatinine clearance >= 60 ml/min). All laboratory data should be evaluated within 7 days before enrollment. 8) Patients with adequate cardiac function (LVEF [left ventricular ejection fraction] evaluated by echocardiography or MUGA scan >= 50%). 9) Patients with normal electrocardiography within 28 days before enrollment. 10) Expected survival >= 90 days. 11) Written informed consent obtained from patients.
Exclusion criteria
Exclusion criteria: 1) Patients who received radiotherapy within 2 weeks before enrollment. 2) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 3) Patients with symptomatic brain metastases or carcinomatous meningitis. 4) Patients with other active malignancies. 5) Patients with active infections. 6) Patients with serious complications. 7) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. 8) Patients with a history of serious drug allergy. 9) Patients who receive continuous corticosteroid administration. 10) Patients who need to receive flucytosine. 11) Patients who need to receive continuous phenytoin or warfarin administration. 12) Patients with serious mental problem. 13) Pregnant or lactating female. 14) HBs antigen positive patients 15) Other patients evaluated to be inadequate to participate in this study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Disease control rate, Overall survival, Time to Treatment Failure, Safety, Translational Research | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed