Actively Recruiting
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Led by Minia University · Updated on 2025-08-29
262
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma (biopsy required).
- Clearly resectable disease based on National Comprehensive Cancer Network criteria without major artery involvement.
- Less than 180-degree tumor contact with portal or superior mesenteric vein and patent vein confluence.
- No evidence of metastatic disease.
- Eastern Cooperative Oncology Group performance status 0-1 and ASA score less than 4.
- Written informed consent provided.
- No previous pancreatic surgery or pancreatic cancer history.
- Adequate organ function: serum creatinine 3 2.0 mg/dL, albumin 3 2.5 g/dL, AST 3 95 U/L, ALT 3 102 U/L, prothrombin time 3 1.8, partial thromboplastin time 3 1.8, leukocyte count >3.5 x10^9/L, platelet count >100 x10^9/L, hemoglobin 3 9 g/dL.
You will not qualify if you...
- Borderline resectable or locally advanced pancreatic or periampullary cancer.
- Tumor located in the body or tail of the pancreas.
- Presence of distant metastases.
- Previous chemotherapy, surgery, or radiotherapy for pancreatic cancer.
- Severe comorbidities preventing surgery or chemotherapy.
- Pregnancy or breastfeeding.
- Other malignant cancers diagnosed in the past 5 years.
- Major surgery or serious injury within the past 28 days.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
Research Team
S
Saleh K Saleh, MD
CONTACT
R
Rabeh K Saleh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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