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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: salehkhairy@mu.edu.eg
• Phone: +201201765401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.