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The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer.
We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine | Experimental | one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection. |
|
| gemcitabine plus celecoxib | Experimental | the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection, and receive additional celecoxib every days during chemotherapy period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | the duration between the date of surgery and the date of disease relapse | Up to approximately 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the duration between the date of surgery and the date of patient death | Up to approximately 60 months |
| Carbohydrate antigen 19-9 | serum Carbohydrate antigen 19-9 level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingbo Liang | Contact | 13666676128 | liangtingbo@zju.edu.cn | |
| Xueli Bai | Contact | shirlybai@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2, and receive additional celecoxib 200mg bid every days during chemotherapy period. |
|
|
| Up to approximately 36 months |
| Quality of Life | assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score | Up to approximately 60 months |
| Common Toxicity Criteria for Adverse Effects | according to Common Toxicity Criteria for Adverse Effects version 4 | Up to approximately 12 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |