Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
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A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
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Ages Eligible for Study:
15 Years to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histological diagnosis of colorectral adenocarcinoma.
Measurable or assessable lesions.
Age: 15 ~ 75 years.
Performance Status (ECOG): 0 ~ 2.
Prior chemotherapy within 2 regimens.
Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
(10) Predicted survival for >8 weeks. (11) Able to give written informed consent.
Severe pleural effusion or ascites.
Metastasis to the central nervous system (CNS).
Active gastrointestinal bleeding.
Uncontrolled ischemic heart disease.
Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
Active multiple cancer.
Severe mental disorder.
Pregnancy, possible pregnancy, or breast-feeding.
Patients with neuropathy ≥ grade 2
Judged to be ineligible for this protocol by the attending physician.