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The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFIRINOX | Experimental | 4 course of FILFIRINOX before surgery |
|
| GEM + nab-PTX | Experimental | 2 course of GEM + nab-PTX before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRINOX | Drug |
| ||
| gemcitabine + nab-paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | surgery is supposed to be performed 3 months after the initiation of chemotherapy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| completion rate of chemotherapy | chemotherapy is supposed to take 3 months | 3 months |
| relative dose intensity | chemotherapy is supposed to take 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000627770 | folfirinox |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| 3 months |
| adverse event | chemotherapy is supposed to take 3 months | 3 months |
| tumor response | tumor response to chemotherapy will be assessed based on Response Evaluation Criteria In Solid Tumor (RECIST). CR: Complete Response, PR: Partial Response, PD: Progression, SD: Stable Disease, NE: Not Evaluable | 3 months |
| disease free survival | 3 years after the surgery |
| overall survival | 3 years after the surgery |
| surgical complication | 1 month after the surgery |
| quality of the tumor | Chemotherapy is supposed to take 3 months. After the completion of chemotherapy, the quality of the tumor will be assessed by imaging findings, such as CT number and Standardized uptake value. | 3 months |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |