advanced gastric cancer
Conditions
Interventions
This nepadjuvant chemotherapy (NAC) regimen is as follows: 80mg/m2 TXL and 25mg/m2 CDDP is administered on days 1, 8, 15 with a 1-week rest, and is totally administered between 2 and 4 courses. After
Sponsors
TC therapy for gastric cancer study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric carcinoma 2) Upper gastrointestinal endoscopy, examinations, or CT revealed the following criteria: i)cStage IIIb-IV and H0 and M0 and P0, ii) Esophageal invasion and cStage IIIa, iii) scirrhous gastric cancer (type3 or type4) and cStage IIIa 3) Thoracic/ abdominal/ pelvic enhanced CT revealed none of the following: mediastinal lymph node metastais, cervical lymph node metastasis, lung metastasis, peritoneal metastasis, liver metastasis, pleural effusion, ascites beyond the pelvis, and other distant metastasis 4) Clinically no sign of distant metastasis 5) No peritoneal metastasis and CY0 by laparoscopy 6) Age between 20 and 80 at registration 7) Performance Status(ECOG) 0 or 1 8) No prior chemotherapy or radiotherapy 9) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection 10) Fair oral intake with or without bypass surgery 13) Blood test i) WBC >= 4,000/mm3, Neu >= 2,000/mm3 and WBC = 8.0 g/dl iii) Platelet >= 100,000/mm3 iv) GOT <= 100IU v) GPT <= 100IU vi) T.bil <= 2.0 mg/dl vii) Creatinin <= 1.5mg/dl viii) ECG: normal 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Serious complications 2) Active multiple cancer 3) Obvious infection or acute inflammatory condition 4) Under treatment with systemic steroid 5) Probable pregnancy, and the period of lactation 6) Difficulty to join the trial due to psychosis or psychotic symptoms 7) Allergy to drugs containing Cremophor EL (including cyclosporin) 8) History of severe drug allergic reaction 9) History of alcoholic allergic reaction 10) Peripheral neuropathy 11) Not fit to the protocol treatment by the physicion's dicision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathorogical response rate for all eligibility population | — |
Secondary
| Measure | Time frame |
|---|---|
| three year survival rate, pathorogical response rate for patients who completed the protocol treatment, the proportion of complete resection, the proportion of patients who completed the protocol treatment, response rate of neoadjuvant chemotherapy, adverse event | — |
Countries
Japan
Contacts
Public ContactHiroko Fukushima
Kyoto University Epidemiological & Clinical Research Information Management
Outcome results
None listed