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The primary endpoint is to evaluate the TFS (time to failure of strategy).
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XELOX plus surgery | Experimental | Eight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated. |
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| XELOX | Active Comparator | Eight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resection of primary lesion | Procedure | Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer |
| Measure | Description | Time Frame |
|---|---|---|
| TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment) | the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijian Guo, doctor | Contact | 13816066360 | mingzhuhuang0718@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35174078 | Derived | Huang M, Yang Y, Li Q, Wang C, Liang L, Zhu X, Zhang W, Chen Z, Huang D, Li W, Zhang X, Zhao X, Qiu L, Geng Q, Yu N, Du W, Sun S, Sheng X, Li X, Guo W. Induction Chemotherapy Followed by Primary Tumor Resection Did Not Bring Survival Benefits in Colon Cancer Patients With Asymptomatic Primary Lesion and Synchronous Unresectable Metastases. Front Oncol. 2022 Jan 31;12:747124. doi: 10.3389/fonc.2022.747124. eCollection 2022. |
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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, |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |