Neoadjuvant chemotherapy versus immediate surgery for resectable pancreatic head and periampullary cancer

Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial

This trial tests if giving chemotherapy before surgery helps people with resectable pancreatic head or periampullary cancer live longer than having immediate surgery followed by chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 262 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Minia University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Minya, Minya Governorate)
• Trial ID: NCT07081360 on ClinicalTrials.gov

What this trial studies

This randomized phase 3 trial enrolls patients with clearly resectable pancreatic head or periampullary cancer and assigns them 1:1 to either neoadjuvant chemotherapy followed by open or laparoscopic pancreaticoduodenectomy or to upfront pancreaticoduodenectomy followed by adjuvant chemotherapy. The primary endpoint is overall survival, with secondary endpoints including R0 resection rate, disease-free survival, and perioperative outcomes. The rationale is that preoperative chemotherapy may treat occult metastatic disease, increase the chance of margin-negative resection, allow more patients to complete planned systemic therapy, and avoid futile surgery in rapidly progressive cases. The trial is conducted at Minia University and follows standard oncologic and surgical protocols.

Who should consider this trial

Good fit: Adults with histologically confirmed pancreatic head or periampullary carcinoma deemed clearly resectable by NCCN imaging criteria, ECOG 0-1, adequate organ function, no prior pancreatic cancer surgery, and no metastatic disease.

Not a fit: Patients with borderline or locally advanced/unresectable tumors, metastatic disease, poor performance status, significant organ dysfunction, or prior pancreatic resection are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase overall survival and R0 resection rates while enabling more patients to complete planned chemotherapy and avoiding unnecessary surgery.

How similar studies have performed: Neoadjuvant therapy has shown benefits in borderline and locally advanced pancreatic cancer and improved R0 rates in some series, but randomized phase 3 evidence specifically for clearly resectable disease remains limited.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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 this trial is running

Minya, Minya Governorate

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

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD

Conditions: Pancreas Cancer, Periampullary Cancer, Periampullary Carcinoma Resectable, Pancreatic Cancer Resectable, Ampullary Cancer, Pancreas Adenocarcinoma, Pancreatic cancer, Neoadjuvant chemotherapy