Colorectal cancer
Conditions
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of colon or rectum. 2) Stage IIIA/IIIB (Japanese classification), or P1, or M1(LYM) 3) >=D2 lymph node dissection 4) Pathological curability is A or B 5) Age between 20 and 75 years 6) ECOG performance status 0-1 7) No prior chemotherapy or radiotherapy 8) Enough oral food and drug intake possible 9) Adequate organ function 10) Able to start between 4 and 6 weeks after surgery 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2) Pregnant or breast-feeding women 3) Severe mental disease 4) Systemic administration of corticosteroids 5) Continuous medication of flusitosine, fenitoin,and/or Warfarin 6) Other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 7) Myocardial infarction within the past 6 months 8) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients ratio with completion of adjuvant XELOX therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, severe adverse events, dose intensity, recurrence free survival, and overall survival | — |
Countries
Japan
Contacts
Public ContactDaisuke Sakai
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Outcome results
None listed