RecruitingPhase 3NCT07081360

Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

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


Sponsor

Minia University

Enrollment

262 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for treating surgically removable (resectable) pancreatic head cancer and nearby cancers: starting with chemotherapy before surgery (neoadjuvant therapy) versus going directly to surgery first. The goal is to determine which approach leads to better outcomes. **You may be eligible if...** - You have confirmed pancreatic head cancer or periampullary cancer (cancer near where the bile duct meets the intestine) that can be surgically removed - Your cancer meets specific imaging criteria showing it can be fully removed surgically - You are in good health (ECOG 0–1, ASA score below 4) and have adequate organ function - You have not had prior pancreatic surgery or cancer treatment **You may NOT be eligible if...** - Your cancer is borderline resectable, locally advanced, or has spread to distant organs - Your tumor is in the body or tail of the pancreas (not the head) - You have had prior chemotherapy, surgery, or radiation for pancreatic cancer - You are pregnant or breastfeeding - You have had major surgery or a serious injury in the past 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant chemotherapy

Neoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy

PROCEDUREUpfront Surgery Group

Pancreaticoduodenectomy followed by adjuvant chemotherapy


Locations(1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

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NCT07081360


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