Advanced gastric cancer
Conditions
Interventions
None listed
Sponsors
Department of Clinical Oncology, Toho University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patient who is pathologically confirmed as HER2 negative adenocarcionoma (2)Patient with gastric cancer of progress or recurrence that is unresectable by initial treatment (3) Measurable lesion is confirmed by CT or MRI before registration within 28 days (4)Patient who has not received any therapy including radiotherapy and chemotherapy except the case that passed as postoperative adjuvant chemotherapy more than 6 months (5) Patient who are possible to be orally administration Capecitabine (6) PS (ECOG) is 0-1 (7) Age from 20 years (8) Written informed consent (9) Life expectancy of more than 3 months (10) Adequate organ function (Neutrophil counts >= 2000/mm3 , Platelets >= 100000/mm3, Hemoglobin >= 9.0g/dL, T-bil <1.5 mg dL, AST,ALT <2.5 x upper normal limit(If a patient have liver metastasis, AST and ALT less than 5 times the upper limit of normal) , Serum creatinine <= 1.2mg/dl, Creatinine clearance >= 60ml/min
Exclusion criteria
Exclusion criteria: (1) Patient who had previously received chemotherapy including a fluorouracil based regimen at least 6 months before registration (2) Patient who had previously received chemotherapy including a Platinum based regimen (3) Patient with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency (4) Active concomitant malignancy (History of active double cancer within 5 years prior to the study) (5) Patient who has severe or uncontrolled complication (infection, pulmonary fibrosis, paralytic intestine, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, uncontrolled hypertension, myocardiac infarction or unstable angina within 6 months before registration) (6) Patient who needs drainage of peritoneal, pleural or pericardial effusion (7) With symptoms due to brain metastasis (8) Active (significant or uncontrolled) bleeding from GI tract (9) Uncontrollable serious mental problem (10) Patient with recurrent gastric cancer have had history of severe diarrhea (>=Grade 3) in previous adjuvant chemotherapy (11) Patients with diarrhea (increase of 4 and more stool frequency per day over baseline or watery stool) at registration (12) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low dose of aspirin) (13) Women who is pregnancy, possible pregnancy or lactation and patients who wish their partner to become pregnant (14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin. (15) Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression free survival Adverse event rate Exploring several predictable biomarkers | — |
Countries
Japan
Contacts
Public ContactYoshinori Kikuchi
Toho University Division of Gastroenterology and Hepatology, Department of Internal Medicine (Omori)
Outcome results
None listed