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Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

NCT07081360 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-08-29

No results posted yet for this study

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

Interventions

DRUG

Neoadjuvant chemotherapy

Neoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy

PROCEDURE

Upfront Surgery Group

Pancreaticoduodenectomy followed by adjuvant chemotherapy

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Saleh K Saleh, MD · Minia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2028-07-20
Completion
2028-08-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081360 on ClinicalTrials.gov