Borderline Resectable Pancreatic Cancer
Conditions
Brief summary
The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.
Interventions
DRUGFOLFIRINOX
Sponsors
Nagoya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015) 2. first treatment for pancreatic cancer 3. performance status 0 or 1 4. adequate one marrow function 5. adequate renal function 6. obtained informed consent
Exclusion criteria
1. other active concomitant malignancies 2. other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine 3. pregnant women 4. no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 3 months | surgery is supposed to be performed 3 months after the initiation of chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relative dose intensity | 3 months | chemotherapy is supposed to take 3 months |
| adverse event | 3 months | chemotherapy is supposed to take 3 months |
| tumor response | 3 months | 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 |
| completion rate of chemotherapy | 3 months | chemotherapy is supposed to take 3 months |
| overall survival | 3 years after the surgery | — |
| surgical complication | 1 month after the surgery | — |
| quality of the tumor | 3 months | 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. |
| disease free survival | 3 years after the surgery | — |
Outcome results
None listed