A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative
Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable
Drug: Peri-operative chemotherapy
Drug: postoperative chemotherapy
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Full eligibility criteria for NCT02912052
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
(1) 18-80 years old, patients with synchronous liver metastatic colorectal cancer confirmed by pathology diagnosis(2) ASA score: I-III (3) MDT evaluation: primary tumor can be cut, liver metastases can get complete resection at R0 level. The adjacent Hepatic segments have enough blood flow to be shared and retain sufficient liver function, liver residual volume is larger than or equal to 50%; general condition of the patient is good enough, without extrahepatic unresectable metastasis, and can tolerate systemic chemotherapy. (4) there are evaluating lesions according to the RESIST 1 edition: at least the single path of the lesions can be accurately measured, and the maximum diameter of the conventional techniques
(traditional physical examination, CT, X, MRI) ≥20mm CT≥10mm or spiral (5) within 3 weeks before entering the group , the laboratory test index and evaluation of the disease show good bone marrow, liver and kidney function reserve: 1) bone marrow function : Hb ≥ 90 g/L, neutrophil absolute value is more than 1.5 x 109/L, the platelet count was larger than 80 x 109/L; 2) renal function: serum creatinine < 1.5 x ULN or the creatinine clearance rate≥ 50 mL/min; 3) liver function: AST and ALT ≤2.5 *ULN(if the disease is caused by tumor, AST and ALT≤5 *ULN, hemobilirubin ≤2 *ULN. (6) signed the informed consent.
(1) the pathological diagnosis is not adenocarcinoma or multiform pathological types.
(2)with clinical symptoms requiring emergency surgery for treatment (complete obstruction, bleeding, intestinal perforation). (3) have received chemotherapy treatment or combined with other the anti-tumor treatment. (4) with serious basic diseases: heart disease, kidney failure, severe liver dysfunction or liver failure, coagulation dysfunction or oral dose of anticoagulant drugs, a baseline proteinuria (total urine protein >1g/d). (5) any other contraindications for the use of chemotherapy treatment (6) patients with pregnancy (7)with previous or existing central nervous system metastasis. (8) there have been cerebrovascular accident or stroke in the past 12 months (9) any other drugs may affect safety or surgical operation history (10) multiple primary colon cancer patients, or suffer from other malignant tumors, or have been systematic chemotherapy (11) with neurological or psychiatric disorders affecting cognitive ability (12)patients cannot accept the treatment because of the psychological, family or social reasons(13) patients with liver metastasis get complete remission after preoperative chemotherapy(14)patients with severe postoperative complications cannot do chemotherapy within the prescribed time (15)liver metastases cannot get hameochronous and R0 standard resection.
All locations for NCT02912052
Jiangsu province hospital
Nanjing, Jiangsu, China, 210029
View full eligibility
Tris trial is registered with FDA with number: NCT02912052. The sponsor of the trial is The First Affiliated Hospital with Nanjing Medical University and it is looking for 240 volunteers for the current phase.
Official trial title: Peri-operative Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable Liver Metastasis: a Prospective Randomized Clinical Trial
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