Gastric or Colorectal cancer
Conditions
Interventions
TS-1 administered 5-days on/ 2-days off Schedule
Sponsors
Japan Community Healthcare Organization(JCHO)Hitoyoshi Medical Center-Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven gastric or colorectal cancer. 2)Gastric cancer: p-stageIIA,IIB(excluding T1 cases and T3N0 StageIIA), IIIA, IIIB and IIIC (Japanese Classification of Gastric Carcinoma The 14th Edition). Colorectal cancer:p-stageII, IIIA, IIIB (Japanese Classification of Colon, Rectum and Anus Carcinoma The 7th Edition, Revised Version). Gastric and colorectal cancer(no hepatic, peritoneal or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis). 3)Gastric and colorectal cancer(D2 or more extensive lymph-node dissection with R0 surgery) 4)Age>= 20 yrs 5)Performance status 0 or 1 6)No previous treatment for cancer expect for the initial gastric or colorectal resection for the primary lesion. 7)adequate oral intake 8)Meet the following criteria for organ functions. i)WBC>=4000/mm3 or the lower limit of the normal range. ii)PLT>=1000000/mm3 iii)T-Bill=<1.5 mg/dl iv)AST,ALT=< 87.5IU/L v)CCr>= 30mL/min 9) Within 8 weeks after surgery. 10) Witten informed consent.
Exclusion criteria
Exclusion criteria: 1)Active co-existing malignancy (synchronous or metachronous malignancy whose disease-free period is within 5 years). 2)Multiple cancer patients except M cancer apparent infection. 3)Severe postoperative complicatoins which do not resolve until registration. 4) Cre>=1.5 mg/dl 5)It corresponds to either the following. i) Uncontrolled diabetes mellitus ii) Uncontrolled hypertension iii) Unatable angia, Cardiac infraction or the history iv) liver cirrhosis v) Interstitial pneumonia, fibroid lung and severe pulmonary emphysema. 6)It corresponds to either the following. i)Pregnant females, possibly pregnant female. ii)females wishing to become pregnant and nursing mothers. iii)Males that are currently attempting to produce a pregnancy. 7)Severe mental disease. 8)Inadequate physical condition, as diagnosed by primary physician. 9)contraindication of TS-1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS(3y), OS, safty | — |
Countries
Japan
Contacts
Public ContactYuri Iwasaki
Japan Community Healthcare Organization(JCHO)Hitoyoshi Medical Center Clinical research center
Outcome results
None listed