Association of MSI, TS, DPD, MVD and EGFR With Chemosensitivity in Stage IV in Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00173472
Verified July 2002 by National Taiwan University Hospital. Recruitment status was: Active, not recruiting
The present project will follow our previous phaseⅡ study of FOLFOX regimens for the treatment of stage Ⅳ colorectal cancer. We will recruit at least 200 patients for this study. The selection of patients will be based on rigorous eligibility criteria. The patients will be allocated based on the expression of each molecular marker (MSI, TS, DPD, MVD and EGFR) and the implementation of chemotherapy. For example, in the examination for the clinical implications of EGFR, the patients will be classified into four groups: EGFR（＋） chemotherapy（＋）; EGFR（＋） chemotherapy（－）; EGFR（－） chemotherapy（＋）; EGFR（－） chemotherapy（－）. Base on the analysis of this 2×2 table, we will clarify the prognostic significance of a specific molecular marker is due to whether the specific molecular marker predicts biological invasiveness and/or chemosensitivity. We believe the present study will have the following significance: （1）To further clarify the mechanisms for the carcinogenesis and progression of CRC; （2）To facilitate the development of novel chemotherapeutic agents; and （3） To gain the experience for the practice of evidence-based medicine.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patients recruited met the following eligibility criteria: (1) The sporadic primary colorectal cancer could be palliatively resected and pathologically confirmed as adenocarcinoma; (2) The metastatic lesions were measurable but unresectable; (3) Karnofsky performance status was ≧50%; (4) The life expectancy was greater than 12 weeks; (5) WBC count was ≧4,000/μL, platelet count was ≧100,000/μL, serum bilirubin was ≦2.0 mg/dL, and serum glucose and electrolyte were normal.
Patients with evident family history of colorectal cancer suggestive of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) were excluded from this study. Moreover, patients with evident carcinosis peritonitis were excluded from this study because their bowel function could not be restored through palliative operation and their prognosis was considered as very poor.