untreated HER2 positive advanced gastric cancer
Conditions
Interventions
Sponsors
Herceptin Database of Shimane Prefecture
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma (included EGJ cancer) (2) Positive HER2 status(IHC3+ or IHC2+/FISH+) (3) Written informed conscent to receive this chemotherapy. (4) Less than 70 years old. (5) Eastern Cooperative Oncology Group (ECOG) performance status 0-2. (6) Life expectancy of at least 3 months after registration. (7) Case which has lesions to be evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline. (8) Adequate organ function as follows: 1. WBC count 4,000-12,000/mm3 2. Neutrophils count more than 1,500/mm3 3. Platelet count more than 100,000/mm3 4. Hemoglobin more than 8.0 g/dl 5. Serum bilirubin level less than 1.5 mg/dl 6. Ast and ALT less than 100 IU/l 7. Serum creatinine level less than 1.2 mg/dl 8. Creatinine clearance more than 30mL/min 9. LVEF more than 50% (9) Patient who is possible of ingestion. (10) Without previous medication history such as radiation therapy, chemotherapy and endocrine therapy (except adjuvant chemotherapy exclude cisplatin). (11) Electrocardiogram was performed within 28 days.
Exclusion criteria
Exclusion criteria: (1) Forbidden case to use capecitabine, Cisplatin and Trastuzumab. (2) R1 operation(histlogically positive PM, OM, LM, VM). (3) Infection or inflammatory case. (4) Severe heart disease. (5) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. (6) Severe ascites and/or pleural effusion. (7) Multiple bone metastasis. (8) Clinical suspicion or previous history of metastasis to brain or meninges. (9) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage. (10)Complicated other active cancer. (11)patient who want to be pregnant and /or pregnant woman. (12)Intend to make pregnant. (13)Active hepatitis type HBs positive. (14)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS: Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR:Overall Response Rate DCR:Disease Control Rate OS:Overall Survival Safety | — |
Countries
Japan
Outcome results
None listed