Gastric cancer
Conditions
Interventions
[Phase I] S-1 with CDDP neoadjuvant chemoradiotherapy is conducted. S-1 is orally administered for 14 days followed by 14 days rest according to body surface area. CDDP is administered intravenously
Sponsors
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) confirmed gastric cancer by endscopic biopsy 2) eligible to below i) clinico pathological clasification type is 3 or 4. ii) has advanced lymph node metastasis 3) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology 4) esophagus invation <= 3cm 5) age: >=20 and <80 6) P.S. 0 or 1 7) No prior treatment 8) possible to oral intake 9) sufficient function of important organs 10) written informed consent
Exclusion criteria
Exclusion criteria: 1) known sever drug allergies 2) with clinically important infection 3) with diarrhea 4) with intestinal paralysis or ileus 5) with interstitial pneumonia or pulmonary fibrosis 6) has history of radiation to chest or ilium 7) has active carcinoma 8) with uncontrollable diabetes mellitus 9) has complication which is clinically probrem 10) with clinically important mental disorder need to treat 11) pregnant or nursing women or women who like be pregnant and willing to get pregnant 12) administered flucytosine 13) being blood transfusion or need to blood transfusion 14) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I estimate the maximum tolerated dose (MTD)and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP Phase II Pathological response rate | — |
Countries
Japan
Outcome results
None listed