clinical stage IIIa-IIIb(IV) gastric cancer
Conditions
Interventions
Docetaxel 35 mg/m2 1-hour IV days 1,15 S-1 80 mg/m2 PO BID days 1-14, every 28 days for 2 cycles followed by gastrectomy with D2 lymph node dissection
Sponsors
Dept. of Surgery and Science, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed adenocarcinoma of the stomach, curative resection possible, CY0, P0, H0 by laparoscopy, Age 20-80 years old, No prior therapy including surgery, radiotherapy or chemotherapy for current disease, patients who can take medication orally, ECOG performance status 0-1, Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions, Written informed consent.
Exclusion criteria
Exclusion criteria: A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix, patients contraindicated to S-1, A history of severe drug hypersensitivity, Uncontrolled medical conditions , Documented or suspected infection, Patients requiring treatment with corticosteroids except for pre-medication, Hepatitis B or C, patients with diarrhea, Pregnant or lactating women and women of child bearing potential not using contraception, Severe psychiatric disorders, Severe edema, Grade 2 or grater peripheral neuropathy, HIV positive, patients judged by the investigator as unfit to be enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of neoadjuvant chemotherapy Treatment completion rate Complete resection rate 3 year relapse free survival 3 year overall survival Adverse events | — |
Countries
Japan
Contacts
Public ContactYoshihiro Kakeji
Kyushu University Dept. of Surgery and Science
Outcome results
None listed