Gastric Cancer
Conditions
Interventions
A course of treatment lasts 21 days, and treatment will be continued until any of the criteria for discontinuation of the protocol treatment are met. On day 1, oxaliplatin 130 mg/m2 and trastuzumab 8
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The individual consents in writing to receipt of the protocol treatment 2)A lead investigator deems that the patient can be treated with the protocol 3)The cancer is histopathologically confirmed (via resected surgical specimens biopsied tissue) to be a common type of gastric cancer (adenocarcinoma) 4)Up to 28 days prior to enrollment, contrast-enhanced CT scans of the trunk (chest,upper abdomen,and pelvis) confirm that 1 or more target lesions is present according to RECIST v1.1 5)The primary tumor or a metastatic focus is determined to be HER2-positive 6)The patient has not previously received chemotherapy, immunotherapy, or radiation therapy 7)When a patient has advanced/recurrent gastric cancer not amenable to curative surgery 8)When palliative surgery or non-curative resection is performed, two weeks should be passed at least after operation and any postoperative complications should be improved. (Laparoscopic examination is excluded from this criterion.) 9)The patient&#39;s age upon enrollment is over 20 and under 80 years 10)The patient has a PS of 0 or 1 on the ECOG Scale 11)The patient is readily able to take medication orally 12)The patient is fully expected to survive for 3 months or longer from the day of enrollment 13)The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient&#39;s laboratory results from up to 14 days prior to enrollment fall within the criteria i)WBC count <=12,000/mm3 ii)Neutrophil coun t>=1,500/mm3 iii)Platelet count >=100,000/mm3 iv)Hemoglobin >=8.0g/dL v)Total bilirubin <=1.5mg/dL vi) AST,ALT <=100IU/L *200 IU/L or lower when liver metastasis is noted vii)Albumin >=2.5g/dL viii)Serum creatinine <=1.5mg/dL ix)Creatinine clearance >=60mL/min 14)The patient has a left ventricular ejection fraction (LVEF) of 50% or more according to echocardiography or a multiple-gated acquisition (MUGA) scan performed up to 14 days prior to enrollment
Exclusion criteria
Exclusion criteria: 1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment 2)The patient has severe drug hypersensitivity (particularly to platinum analogs,5-FU,S-1,or trastuzumab) 3)The patient has peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 4)The patient has an active infection 5)The patient has poorly controlled hypertension 6)The patient has poorly controlled diabetes 7)If a 12-lead ECG reveals marked ECG abnormalities up to 14 days prior to enrollment or the patient has heart disease that may pose a problem 8)The patient has severe pulmonary disease 9)he patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction 10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions 11)The patient is receiving phenytoin, warfarin potassium,or flucytosine 12)The patient has moderate or more severe fluid accumulation in body cavities,such as pleural effusions and ascites,that continually requires treatment such as drainage 13)The patient has brain metastasis or clinical features suggesting brain metastasis 14)The patient has extensive bone metastasis (as determined by the patient&#39;s primary physician) 15)The patient has watery diarrhea (watery stool)(Grade 2 or worse) 16)The patient has active multiple cancers 17)The patient has a history of receiving platinum-based antineoplastic agents (e.g. oxaliplatin and cisplatin) 18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner 19)The patient tests positive for HBsAg or antibodies to HCV (Date of testing required) 20)A patient who is deemed to need antiviral therapyb (as of enrollment) for HBV-related hepatitis 21)A lead investigator or the patient&#39;s primary physician otherwise deems that participation in this trial is not appropriate for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response proportion (RECISTv1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile*1, progression-free survival (PFS) , overall survival (OS), time-to-treatment failure (TTF), Duration of treatment , time to failure of strategy (TFS) , dose intensity *1 Particular attention will be paid to thrombocytopenia, peripheral sensory neuropathy, and allergic reactions. | — |
Countries
Japan
Contacts
Public ContactKSCC Research Secretariat
Clinical Research Support Center Kyushu KSCC Research Secretariat
Outcome results
None listed