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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy plus surgery | Experimental | Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated. |
|
| Chemotherapy alone | Active Comparator | Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resection of primary tumor | Procedure | resection of primary lesion with unresectablely metastatic colon cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival 1 | The first progression time after diagnosis | 3-year |
| Progression-free survival 2 | The first progression time after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxiang Li | Contact | +8613761291659 | 1149lxx@sina.com | |
| Qingguo Li | Contact | +8618918298120 | qingguoli@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C519688 | XELOX |
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| XELOX | Drug | Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle |
|
| mFOLFOX6 | Drug | Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1,2400 mg/m2 CIV 46h, d1 |
|
| 3-year |
| The rate of adverse events resulted from chemotherapy | The ratio of the number of patients experienced adverse events to the total patients | 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 | 3-month, 6-month, 9-month, 12-month, 18-month, 24-month |
| Objective response rate | 1-year |
| The rate of postoperative complications | The ratio of the number of patients with postoperative complications to the total patients | 1-year |
| The proportion of surgical intervention in control group | 1-year |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |