HER2 negative gastric cancer
Conditions
Interventions
Cisplatin 80 mg/m2 is given as 2 hours intravenous infusion on day1 with the adequate hydration. Capecitabine is administrated orally twice daily. The dosage of capecitabine is as follows: body surfa
1.36 m2, 2,400 mg/day
1.36 m2 <
1.66 m2, 3,000 mg/day
1.66 m2 <
= BSA<
1.96 m2, 3,600 mg/day
1.96 m2 <
= BSA, 4,200mg from day 1 to day 14. The treatment was continued every 3 weeks until the discontinuation criteria were met.
Sponsors
Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient has pathologically comformed gastric adenocarcinoma. 2) HER2 negative (HER2 positive is defined as HER2 (3+) by IHC or HER2 (2+) and FISH positive. HER2 negative is defined as excluding HER2 positive) 3) Recurrence is confirmed by CT or MRI before registration within 28 days. 4) No prior chemothrapy or radiotherapy for recurrent gastric cancer. 5) No neoadjuvant treatment (chemotherapy and or radiotherapy). 6) An Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1 7) R0 resection was carried out and S-1 was administrated asadjuvant chemotherapy. 8) Recurrence is confirmed after or during S-1 treatment for more than 6 months. 9) Oral intakes are possible. 10) Life expectancy of at least 3 monts. 11) Provision of written imformed concent in accordance with govement and institutional guidelines. 12) Age 20 or older. 13) Patient judged eligible for this protocol by the attending physician. . 14) Adequate organ function defined by the following data within 14 days before registration: 1.WBC: 3,000/mm3 or more 2.Neutrophiles: 1,500/mm3 or more 3.Platelets: 100,000/mm3 or more 4.Hb: 8.0 g/dl or more 5.AST(GOT) and ALT(GPT): 100 IU/L or less (in case with metastatic liver tumor, 200 IU/L or less) 6.total bilirubin: less than 2.0 mg/dl 7.creatinine clearance: more than 60ml/minby the actual measurement or the calculation of Cockcroft-Gault
Exclusion criteria
Exclusion criteria: Exclusion criteria were as follows: 1) Cy1. 2) Patients who have been treated with platinum preaviously. 3) A history of drug sensitivity to fluoropyrimidine or platinum 4) Active double cancer within 5 years (except carcinoma in situ and skin cancer which were cured) 5) Active infection or inflammation (fever with 38.0 degree or higher) 6) Active hepatitis 7) Severe heart disease or that history within 1 year. 8) Patient with serious complications such as gastrointestinal paralysis, ileus, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetis mellitis, renal failure, liver damage, and liver cirrhosis. 9) Patient who needs treatments of phenytoin or warfarin. 10) Chronic diarrhea (diarrhea of more than 4 times daily, or watery diarrhea) 11) Active GI tract bleeding. 12) Patient who need drainage of peritoneal, pleural or pericardial effusion. 13) Clinically suspicious of brain metastasis, or that history. 14) Pregnancy, possible pregnancy or lactation. 15) Men who wish their partner to become pregnant 16) Treatment or that previous history of psychiatric diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression free survival (PFS) | — |
Countries
Japan
Contacts
Public ContactMasanobu Takahashi
Tohoku Clinical Oncology Research and Education Society (T-CORE) Administration Office
Outcome results
None listed