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| Name | Class |
|---|---|
| Peking University | OTHER |
| Sanofi | INDUSTRY |
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This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis |
|
| 2 | Active Comparator | no neoadjuvant chemotherapy, resect the liver metastasis directly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemotherapy with oxaliplatin and capecitabine | Drug | oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w) |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival rate | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | at the time of pathological report | |
| survival rate and over survival | 5 year | |
| surgery related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhou jing, MD | Contact | 86-10-66583821 | zhoujing58@sohu.com | |
| Xiaotian Zhang, MD | Contact | 86-10-88196561 | zhangxt@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Shan Wang, MD | Peking University People's Hospital, Department of General Surgery | Principal Investigator |
| Lin Shen, MD | Peking University, School of Oncology, Department of GI Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University, School of Oncology | Recruiting | Beijing | Beijing Municipality | 100036 | China |
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| resection of liver metastasis | Procedure | surgery with the aim of R0 resection |
|
| peri-operation period |
| response rate and safety of XELOX as a neoadjuvant regimen | no time frame |
| Peking University, People's Hospital | Recruiting | Beijing | 100044 | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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