KCT0003077
Recruiting
未知
Randomized-controlled trial to assess the safety and efficacy of preoperative chemotherapy in comparison with postoperative chemotherapy in patients with locally advanced colon cancer
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Kyungpook National University Medical Center
- Enrollment
- 708
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pathologically confirmed colon cancer (adenocarcinoma)
- •2\. Age 20 to 75
- •2\. Eastern Cooperative Oncology Group score 0\-2
- •3\. Colon adenocarcinoma that were located above more than 15 cm from the anal verge
- •4\. Clinically diagnosed cT3\-4 (AJCC 7th edition) and longitudinal tumor length \= 4cm
- •5\. Clinical diagnosis of carcinoma involving a single colon segment
- •6\. Patients with adequate hepatic (bilirubin\=1\.5×ULN (upper limit of normal)), renal (GFR\>50ml/min by Wright or Cockroft formula), and bone marrow (WBC\>3\.0×109/L, Platelet\>100×109/L) function
- •7\. If female and of childbearing potential, must: Have a negative pregnancy test \=72hours prior to initiating study and agree to avoid pregnancy during and for 6 months after study treatment
- •8\. If male with a partner of childbearing potential, must: Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
- •9\. No history of chemotherapy
Exclusion Criteria
- •1\. Rectal cancer located within 15 from the anal verge
- •2\. Tumor removal status by colonoscopy (EMR or ESD)
- •3\. Distant metastasis (Extra\-mesocolic LN, liver, lung, peritoneum, or other distant metastasis )
- •4\. Peritonitis from cancer perforation or acute colonic obstruction
- •\*Except, if obstruction is relieved by stent or stoma
- •5\. Potentially unresectable tumor
- •6\. Multiple primary colorectal cancers
- •7\. Familial polyposis, hereditary non\-polyposis colorectal cancer
- •8\. Inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
- •9\. Non\-adenocarcinoma pathology
Outcomes
Primary Outcomes
Not specified
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