gastric cancer
Conditions
Interventions
1) Treatment period for chemoradiation is 28 days on level 0 or level 1, and 35 days on level 2. 2) TS-1 is administered twice a day (morning and evening). On level 0, 60 mg/m2/day of TS-1 is to be
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age:older than 75 years old at the registration 2) histologically proven gastric carcinoma by endoscopic detection 3) patients with large type 3 or type 4 gastric cancer Large:the size of cancer is larger than 8 cm 4) without peritoneal metastasis (P0) and negative in lavage cytology (CY0) by laparoscopic examination 5) expected curative resection (R0) 6) without esophageal invasion longer than 1.1 cm or duodenal invasion 7) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 8) without any prior chemotherapy, radiation therapy and/or surgical treatment 9) without any bleeding from main lesion or intestinal stenosis 10) with good functions of important organs a) WBC: =>3000 and <12,000/mm3 b) Neutrophil: =>1,500/mm3 c) Hemoglobin: =>8.0 g/dl d) Platelet: =>100,000/mm3 e) AST, ALT: =< 100 IU/L f) T.bil.: =<1.5 mg/dL g) creatinine clearance: =>40 ml/min CC by Cockcroft-Gault method is available When CC is between 40 and 59, TS-1 is to be one-level dose down. 11) Patients can take food orally 12) with written Informed Consent 13) without peritoneal adhesion
Exclusion criteria
Exclusion criteria: 1) with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 2) with a history of severe allergy against medicine 3) with infectious disease and febrile condition (over 38 centigrade) 4) pregnant or nursing female 5) male expecting pregnancy of partner 6) with a history of cardiac infarction within 6 months 7) under continuous steroids medication 8) Patients who are received systemic continuous administration of flucytosine, phenytoin or warfarin 9) bleeding from gastrointestinal tract 10) with uncontrollable diarrhea (watery stool and/or frequent diarrhea) 11) with HBs antigen+, and/or HCV-antibody+ 12) with severe diseases: autoimmune diseases, intestinal paralysis, interstitial pneumonitis/pulmonary fibrosis, ischemic cardiac diseases 13) Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I:rate of dose limiting toxicty Phase II:Response Rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I:Response Rate (RR), Safety(frequency of adverse events, ncidence of a postoperative complication) Phase II:Overall Survival Rate(OS), Progression Free Survival Rate(PFS), Time To Failure(TTF), Disease Control Rate (DCR), Incidence and Grade of Adverse Events, Relative Performance, Rate of Patients who receive next treatment | — |
Countries
Japan
Contacts
Public ContactMotohiro Imano
Kindai University Faculty of Medicine Department of Surgely
Outcome results
None listed