colon cancer
Conditions
Interventions
Administration of the celecoxib
no treatment
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed colon cancer (2) Histological stage II orIII colon cancer or rectosigmoid cancer resected with D2 or more lymph node dissection (3) Able to start protocol treatment within 10 weeks of surgical procedure (4) Age<80 years old (5) Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1 (6) No prior chemotherapy or radiotherapy for target disease (7) Preservation of primary organ function white blood cell(WBC)count> 3,000/mm3 and <12,000/mm3, neutrophil count>1,500/mm3, haemoglobin >8.0 g/dl, platelet count>100,000/mm3, aspartate aminotransferase, alanine aminotransferase (ALT) <100 IU/L, serum total bilirubin <1.5 mg/dl, serum creatinine <1.5 mg/dl (8) After basic screening, informed consent to participate in the study was obtained from patients
Exclusion criteria
Exclusion criteria: (1) History of severe hypersensitivity including aspirin-induced asthma (2) Severe dysesthesia including functional disorder (3) Cardiovascular risk factor (including history of poorly controlled hypertension, unstable angina, myocardial infarction or brain infarction. NYHA III or IV cardiac failure.) (4) History of gastrointestinal ulcer including perforation or intestinal bleeding (5)Disease-free less than 5 years (6) Concurrent infectious disease (7) Serious concurrent mental disease (8) Uncontrollable sever concurrent disease (9) Having analgesic drugs (excluding low dose aspirin <100mg per day) (10) Pregnant or lactating, or planning to become pregnant (11) Judged to be unsuitable for participation in the clinical study by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of at least grade 2 injection pain | — |
Countries
Japan
Contacts
Public ContactMitsuyoshi Ota
Yokohama City University Gastroenterological surgery
Outcome results
None listed