colorectal cancer
Conditions
Interventions
A: Observasion (surgely-alone). Patients in this group are observed without any adjuvant chemotherapy.
B: Capecitabine for 6 month: Capecitabine (1,250 mg/m2) is orally administered twice daily after
Sponsors
Ueno Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven colorectal adenocarcinoma. 2) Tumor is mainly located between cecum and lower rectum. 3) Tumor resection with D2 or D3 lymph node dissection with open or laparoscopic approach was performed, regardless of with or without lateral lymph node dissection (Robotic surgery is allowed for enrollment). 4) R0 resection was performed. 5) pStage II cancer (JSCCR classification 9th ed.). 6) Tumor is associated with at least one following factors; (a) Depth of tumor: pT4, (b) Tumor budding: BD3, (c) Perineural invasion: Pn1, (d) Desmoplastic reaction (DR) category: intermediate/immature 7) Between 28 to 56 days after surgery. 8) Age at registration is of 20 to 80 years old. 9) ECOG Performance status is 0 or 1. 10) No prior chemotherapy. 11) It is possible to take foods and drugs orally. 12) Major organ function is preserved. (a) ANC>=1,500/mm3, (b) PLT>=100,000/mm3, (c) T-bil=50 mL/min, 13) 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) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy. 5) Severe psychological disease. 6) Continuous systemic corticosteroid or immunosuppressant treatment. 7) Uncontrollable diabetes mellitus. 8) Uncontrollable hypertension. 9) Unstable angina pectoris, or history of myocardial infarction within 6 months. 10) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 11) Regularly using phenytoin. 12) Severe postoperative complicatoins which do not resolve until registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) / Overall survival (OS) / Adverse events / Incremental cost-effectiveness ratio (ICER) | — |
Contacts
Public ContactYoshiki Kajiwara
National Defence Medical College Hospital
Outcome results
None listed