Advanced Gastric Cancer
Conditions
Interventions
1st course S-1: 80mg/m2 Day 1-14 Cisplatin: 20mg/m2 Day 1, 15 Radiation: 40Gy/20Fr (Primary tumor and regional lymph node) 2nd course S-1: 80mg/m2 Day 1-28 Cisplatin: 20mg/m2 Day 1, 15, 29
Sponsors
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) adenocarcinoma of the stomach 2) lymph node metastasis (evaluable by RECIST ver. 1.1) 3) The depth is either T3 or T4 4) The invasion to esophagus is within 3cm. 5) Age: From 20y.o to 75 y.o. 6) ECOG PS 0 or 1 7) No prior neither chemotherapy nor radiotherapy 8) No prior gastrectomy 9) Sufficient function of important organs 10) Possible oral intake 11) written informed consent
Exclusion criteria
Exclusion criteria: 1) contraindication of either S-1 or cisplatin 2) with severe infection 3) with interstitial pneumonia or pulmonary fibrosis 4) with severe diarrhea 5) with severe complication (intestinal paralysis, ileus, diabetes, renal dysfunction, liver dysfunction) 6) with other active malignant disease 7) pregnant or nursing women or women who like be pregnant and willing to get pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of neoadjuvant chemoradiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response rate, compliance of neoadjuvant therapy, compliance of adjuvant therapy, curable resection rate, rate of adverse event, 3-year Relapse-free survival, 3-year Overall survival | — |
Countries
Japan
Contacts
Public ContactHirofumi Kawakubo
School of Medicine, Keio University Department of Surgery
Outcome results
None listed