Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer (PC) patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesions which are not being detected in early disease status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting.
There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and periampullary cancer and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC and periampullary Cancer.
This randomized controlled trial compares neoadjuvant chemotherapy followed by surgery versus upfront surgery for patients with clearly resectable pancreatic head cancer and periampullary cancer. The study aims to determine if neoadjuvant chemotherapy improves overall survival compared to immediate surgery followed by adjuvant chemotherapy.
Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).
Eastern Cooperative Oncology Group (ECOG)=0-1 & American Society of Anesthesiologists (ASA) score <4.
Written informed consent.
Medical history without previous pancreatic resection or pancreatic cancer.
Borderline resectable or locally advanced pancreatic or periampullary cancer.
Tumor at the body or tail of the pancreas.
Distant metastases.
Prior chemotherapy , surgery or radiotherapy for pancreatic cancer.
Parallel
Neoadjuvant chemotherapy
DrugNeoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy
Upfront Surgery Group
Procedure/SurgeryPancreaticoduodenectomy followed by adjuvant chemotherapy
Overall survival rate
Overall survival will be measured as the time between date of randomization and date of death from any cause or date of last follow-up if alive.
Disease-free survival (DFS)
Disease-free survival will be measured as the time between date of surgery and date of disease recurrence
Local recurrence rate
Local recurrence is defined as recurrence in the pancreatic resection margin, residual pancreas, and regional lymph nodes.The local recurrence is defined as the percentage of patients who had recurrence after the surgical resection.
Recurrence rate
The proportion of patients who experienced recurrence within 3 years from the date of surgery.
Time to locoregional recurrence (TLR)
Time to locoregional recurrence (TLR) is defined as the time from date of surgery to the date of locoregional recurrence after resection.
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