Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

Recruiting now · Phase 3

Conditions studied: Pancreas Cancer, Periampullary Cancer, Periampullary Carcinoma Resectable, Pancreatic Cancer Resectable, Ampullary Cancer, Pancreas Adenocarcinoma

In brief

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.

Key facts

Study ID: NCT07081360
Run by: Minia University
People needed: 262
Starts: 2025-07-20
Expected to finish: 2028-08-20
Last updated by the study team: 2025-08-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).
Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging:
No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery .
Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence No evidence of metastatic disease.
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.
Adequate organ function (liver, kidney, bone marrow) (serum creatinine ≤2.0 mg/dL,reference range 0.5-1.20 mg/dL; serum albumin ≥2.5 g/dL, reference range 3.5-5.3; aspartate aminotransferase (AST) ≤95 U/L, reference range 0-38; Alanine aminotransferase (ALT) ≤102 U/L, reference range 0-41; prothrombin time ≤1.8, reference range 0-1.20; partial thromboplastin time ≤1.8, reference range 0.82-1.25; leukocyte count greater than 3.5×109/L, reference range 4.2-9.0; platelet count greater than 100×109/L, reference range 130-400; hemoglobin ≥9 g/dL, reference range 12-16).

You may not qualify if…

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.
Severe comorbidities precluding surgery or chemotherapy.
Pregnancy or lactation.
Other neoplastic diseases (malignant)diagnosed in the past 5 years.
Major surgery or traumatic event in the past 28 days.

Where it is running

Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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