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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
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the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX | Active Comparator | In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6. |
|
| FOLFIRI | Experimental | in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival（DFS） | The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared. | 3-year disease-free survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups. | 5-year survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YULONG HE, PhD | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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| Irinotecan | Drug | In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006571 |
| Heterocyclic Compounds |