Stage III colorectal cancer
Conditions
Interventions
A:Placebo. Patients in this group receive placebo for 3 years with adjuvant chenmotherapy(mFOLFOX6, CAPOX ,or capecitabine).
B:Aspirin. Patients in this group receive aspirin, at a dose of 100 mg for
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven colorectal adenocarcinoma. 2) Tumor is mainly located between cecum and upper rectum, excluding appendix and that invades to lower rectum. 3) Tumor resection with D2 or D3 lymph node dissection was performed. 4) R0 resection was performed. 5) Stage III cancer (UICC TNM classification 7th ed.). 6) No synchronous colorectal cancer which invade muscularis propria or deeper. 7) Age at registration is of 20 to 80 years old. 8) ECOG Performance status is 0 or 1. 9) No prior chemotherapy or radiation therapy. 10) No anti-platelet drug or anti-coagulant drug at registration. 11) No periodic oral NSAIDs at registration. 12) No history or complication of gastric or duodenal ulcer 13) No history of bronchial asthma. 14) No inflammatory bowel disease and hemorrhagic disease. 15) It is possible to take foods and drugs orally. 16) Within 8 weeks after surgery. 17) Major organ function is preserved. ANC>=3,000/mcl, PLT>=75,000/mcl, T-bil<=2.0 mg/dl, GOT<=100 IU/L, GPT<=100 IU/L , Cr<=1.5 mg/dl 18) The following chemotherapy will be performed as adjuvant chemotherapy. 1.Cpecitabine,2.mFOLFOX6,3.CAPOX 19) Witten informed consent is obtained
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies 2) Infections which needs systemic treatment. 3) Body temperature is higher than 38 degrees centigrade at registration. 4) History of allergy aspirin or salicylic acid. 5) Female during pregnancy, within 28 days of postparturition, or during lactation. 6) Severe psychological disease. 7) Continuous systemic corticosteroid or immunosuppressant treatment. 8) Severe postoperative complicatoins which do not resolve until registration. 9) Regularly using phenytoin. 10) Uncontrollable diabetes mellitus. 11) Uncontrollable hypertension. 12) Unstable angina pectoris, or history of myocardial infarction within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Relapse-free survival, Relative dose intensity, Adverse events, Sever adverse events. | — |
Countries
Japan
Contacts
Public ContactAtsuo Takashima
JCOG1503C Coordinating Office Gastrointestinal Medical Oncology, National Cancer Center Hospital
Outcome results
None listed