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The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.
We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again. |
|
| 2 | Active Comparator | folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy (TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE + folfox 4 | Procedure | tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml folfox4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years after operation |
| Measure | Description | Time Frame |
|---|---|---|
| resection rate of liver metastasis progression-free survival | 5 years after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianmin xu, MD, PHD | Contact | 008613501984869 | xujmin@yahoo.com.cn | |
| yunshi zhong, MD | Contact | 008613564623481 | zhongamy2002@126.com |
| Name | Affiliation | Role |
|---|---|---|
| jianmin xu, MD, PHD | department of general surgery, zhongshan hospital, fudan university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| TAC + folfox4 |
| Procedure |
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4 |
|
| 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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