The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
627
resection of primary lesion with unresectablely metastatic colon cancer
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1,2400 mg/m2 CIV 46h, d1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGOverall survival
Time frame: 5-year
Progression-free survival 1
The first progression time after diagnosis
Time frame: 3-year
Progression-free survival 2
The first progression time after randomization
Time frame: 3-year
The rate of adverse events resulted from chemotherapy
The ratio of the number of patients experienced adverse events to the total patients
Time frame: 3-year
The quality of life postoperatively
The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Time frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Objective response rate
Time frame: 1-year
The rate of postoperative complications
The ratio of the number of patients with postoperative complications to the total patients
Time frame: 1-year
The proportion of surgical intervention in control group
Time frame: 1-year
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