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| ID | Type | Description | Link |
|---|---|---|---|
| StateKeyLab | Registry Identifier | StateKeyLab |
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| Name | Class |
|---|---|
| Tianjin Union Medical Center | OTHER |
| Beihua University | OTHER |
| Chengdu Medical College | OTHER |
| Shanghai Jiao Tong University School of Medicine |
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This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer.
This study will examine a new combination of drugs: Capecitabine and Oxaliplatinfor for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer. In the present trial, we will study the combination of these two drugs in patients with colorectal cancer among Chinese population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-fluorouracil plus oxaliplatin | Experimental | patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine and Oxaliplatin | Drug | Capecitabine and Oxaliplatin will be under the NSCLC guideline |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs | 7 years | |
| To determine the relapse of patients with metastatic colorectal cancer received the combination of drugs | 7 years | |
| To determine prognosis of patients with metastatic colorectal cancer received the combination of drugs | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the time to progression of metastatic colorectal cancer after treatment | 7 years |
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Inclusion Criteria:
Age:
•18 and over
Performance status:
•WHO 0-2
Life expectancy:
•Not specified
Hematopoietic:
Hepatic:
Renal:
•Creatinine clearance greater than 30 mL/min
Cardiovascular:
More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
Other:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dake Chu, M.D. | Contact | 86-29-84774516 | chudake@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dake Chu, M.D. | Air Force Military Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Key Laboratory of Cancer Biology | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| OTHER |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |