Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

NCT07081360 | Recruiting Phase 3 DMC

• 1 other identifier: 1563/06/2025
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Cancer; Periampullary Cancer; Periampullary Carcinoma Resectable; Pancreatic Cancer Resectable; Ampullary Cancer; Pancreas Adenocarcinoma

Keywords

Pancreatic cancer; Neoadjuvant chemotherapy; Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 years.

Secondary Outcomes (16)

• Disease-free survival (DFS)

  Up to 3 years post-procedure.

• Local recurrence rate

  Up to 3 years post-procedure.

• Recurrence rate

  Up to 3 years post-procedure.

• Time to locoregional recurrence (TLR)

  Up to 3 years post-procedure.

• Response rate in neoadjuvant setting

  12 to 16 weeks.

Study Arms (2)

Neoadjuvant chemotherapy group (mFOLFIRINOX)

EXPERIMENTAL

Neoadjuvant chemotherapy(mFOLFIRINOX) followed by pancreaticoduodenectomy

Drug: Neoadjuvant chemotherapy

Upfront Surgery Group

ACTIVE COMPARATOR

Pancreaticoduodenectomy followed by adjuvant chemotherapy

Procedure: Upfront Surgery Group

Interventions

Neoadjuvant chemotherapy DRUG

Neoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy

Neoadjuvant chemotherapy group (mFOLFIRINOX)

Upfront Surgery Group PROCEDURE

Pancreaticoduodenectomy followed by adjuvant chemotherapy

Upfront Surgery Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (22)

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• Ye M, Zhang Q, Chen Y, Fu Q, Li X, Bai X, Liang T. Neoadjuvant chemotherapy for primary resectable pancreatic cancer: a systematic review and meta-analysis. HPB (Oxford). 2020 Jun;22(6):821-832. doi: 10.1016/j.hpb.2020.01.001. Epub 2020 Jan 27.

  PMID: 32001139 BACKGROUND

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

+201201765401; salehkhairy@mu.edu.eg

Rabeh K Saleh, MD

CONTACT

+201220065443; Rabeh.Saleh@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Two parallel groups: neoadjuvant chemotherapy followed by surgery versus upfront surgery

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 23, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): August 20, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)