gastric cancer
Conditions
Interventions
DTX and TS-1 are administrated 45 days after R0 operation. One course includes Docetaxel 40mg/m2 on day 1 + TS-1 80mg/m2 between day 1 and day 14, and 7 days rest.
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)gastric cancer proven histologically 2)Patients who underwent D2 lymph node dissection to be curative operation 3)gastric cancer in Stage lllA or lllB by the japanese Classification pf Gastric Carcinoma(The 13th Edition) 4)patients older than 20 y.o. and younger than 80 y.o. 5)PS(ECOG)=0-1 6)without any treatment before(radiation therapy, Chemotherapy and/or hormone therapy) 7)patients who can take mesicine orally 8)without any severe complications and limited in the following date WBC : 3,000/mm3<= and >=12,000/mm3 Neutrophile : 2,000/mm3 Hemoglobin : 9.0g/dl<= Platelet : 100,000/mm3 T.bil. : 1.5mg/dl>= AST,ALT : 100IU/L>= creatinine : 1.2mg/dl 9)with written Informed Consent
Exclusion criteria
Exclusion criteria: 1)Patients with double cancers (simultaneous or different time) Following cases are eligeble : 1.carcinoma in situ of cervical cancer and/or focal colon cancer in adenoma 2.small multiple cancers whose stages are lower than main cancer 3.double early cancers removed by EMR/EDS 2)patients who has contraindication to TS-1 3)patients who need Flucitosine,Fenitoin and/or Walfarin 4)patients who have a history of severe allergy against medicine in grade 3 or 4 5)patients who have a history of severe allergy against medicine including polysolvate 80 6)with interstitial pneumonia 7)with severe diseases(intestinal paralysis, ileus, uncontrollable DM, Cardiac failure, liver dysfunction) 8)with watery diarrhea 9)Females who are pregnent,nursing or possibility of pregnancy, or have a plan to have baby in future 10)Males who have a plan to have their own baby 11)with HIV (positive) or liver cirrhosis/active hepatitis 12)Edema which needs treatment 13)patients whom doctor in chief decides not to register to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| six months durability rate of TS-1 administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Deasease-free survival, Advers events, Twelve months durability of TS-1 administration | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed