left-sided obstructive colorectal cancer
Conditions
Interventions
Preoperative chemotherapy:
Two courses of CAPOX therapy after SEMS or stoma decompression.
Surgery:
Surgery is performed as soon as the patient has recovered from the adverse events of chemotherapy.
Sponsors
Miura Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven colorectal adenocarcinoma. 2) The lower margin of the tumor is D, S, or RS. 3) It is confirmed to be inability to pass scope during colonoscopy and be CROSS 0-1 before decompression. 4) Successful decompression with stent or stoma. 5) Eastern Cooperative Oncology Group performance status (PS) 0-1. 6) Age at enrollment is 18 years or older. 7) Adequate hematological, hepatic, renal and metabolic function parameters. 8) Written informed concent.
Exclusion criteria
Exclusion criteria: 1) Invasion to other organs. 2) Distant metastasis. 3) CT after decompression shows residual obstructive colitis or abscess formation. 4) Active multiple carcinomas (intraepithelial carcinoma is acceptable). 5) Bone marrow suppression (neutrophil count <1,500/mm3, platelet count <100,000/mm3). 6) Severe renal impairment (creatinine clearance* <30 mL/min). 7) Prior chemotherapy for the subject disease. 8) Previous radiotherapy in the pelvic region. 9) Drug sensitivity to study medications. 10) History of major surgery (implantable central venous reservoir placement and stoma placement are acceptable) within 28 days prior to enrollment. 11) History of clinically severe cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment. 12) Severe complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.) 13) Pregnant woman, lactating woman, a woman who intends to be pregnant or a man whose partner wishes to become pregnant. 14) Other cases deemed by the investigator to be inappropriate for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year disease-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative chemotherapy completion rate, preoperative chemotherapy adverse event rate, R0 rate, postoperative chemotherapy completion rate, postoperative chemotherapy adverse event rate, complication rate after primary tumor resection, complication rate after stoma closure, 3 year permanent stoma rate, 3 year local recurrence rate, 3 year overall survival rate | — |
Contacts
Public ContactTakuya Miura
Hirosaki University Hospital
Outcome results
None listed