Borderline Resectable Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma
Conditions
Keywords
neoadjuvant chemotherapy, albumin bound paclitaxel, mFOLFIRINOX
Brief summary
This is a prospective, single-center, randomized, controlled phase Ⅲ study.
Detailed description
Three hundred patients with borderline resectable and locally advanced pancreatic cancer will be randomized 1:1 (150 :150) to the AG and mFOLFIRINOX chemotherapy groups and to observe the overall survival. The AG regimen: albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycles. MFOLFIRINOX: Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles. After neoadjuvant chemotherapy, the surgery will be evaluated according to the patient's tumor and systemic condition. The first cycle of adjuvant chemotherapy begins 4-8 weeks after radical resection, and the choice of adjuvant chemotherapy regimen depends on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy maintains the original regimen.Adjuvant chemotherapy has 4 cycles of treatment. Relevant examinations were performed before and after each cycle of medication to assess safety events, imaging review was performed every 2 cycles during the treatment period and every 3 months during the follow-up period.
Interventions
Albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle.
DRUGmFOLFIRINOX
Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
open-label
Intervention model description
Three hundred patients with borderline resectable and locally advanced pancreatic cancer are randomized 1:1 to the AG and mFOLFIRINOX chemotherapy groups and to observe the total survival.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed content obtained prior to treatment * Age ≥18 years and ≤ 80 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Radiographically confirmed after borderline resectable or locally advanced pancreatic adenocarcinoma. * No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy. * No any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy. * No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards) * White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb)≥ 9 g/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN * Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN * Comply with research visit plans and other program requirements.
Exclusion criteria
* with other systemic malignancies * Patients who were treated with any other anti-tumor therapy prior to neoadjuvant chemotherapy, including intervention chemoembolization, ablation, radiotherapy, chemotherapy and molecular targeted therapy. * used any other study drug within 7 days prior to enrollment; * Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled * History of allergic reactions attributed to compounds of similar chemical or biological composition to study drug and alike. * Patients who are using and expected to use warfarin in long term * Patients may leave the observation for 14 days or more during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | from randomization to death, up to 36 months | To evaluate the overall survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence free survival | from randomization to recurrence, up to 36 months | To evaluate the recurrence free survival of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy |
| objective response rate | up to 36 months | To evaluate the objective response rate of patients with borderline resectable and locally advanced pancreatic cancer after treated neoadjuvant chemotherapy |
| resection rate | up to 36 months | The proportion of patients who become operable from inoperable after neoadjuvant chemotherapy. |
| R0 resection | up to 36 months | The proportion of R0 resection among patients who undergo operations. |
| postoperative complications | up to 36 months | The incidence of postoperative complications |
Countries
China
Contacts
Primary ContactXian-Jun Yu, MD, PhD
Backup ContactWen-Quan Wang, MD, PhD
Outcome results
None listed