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2025-07-20
2028-07-20
2028-08-20
262
NCT07081360
Minia University
Minia University
INTERVENTIONAL
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
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.
Pancreatic cancer is the seventh highest cause of death from cancer worldwide, with only 20% of patients presenting with resectable disease. Despite potentially curative resections, 5-year survival remains at 20%. This study evaluates whether neoadjuvant chemotherapy can improve outcomes by eliminating occult metastatic disease and improving resection margins. Patients with clearly resectable pancreatic head cancer or periampullary cancer will be randomized 1:1 to either neoadjuvant chemotherapy followed by open or laparoscopic pancreaticoduodenectomy (Arm A) or upfront laparoscopic pancreaticoduodenectomy followed by adjuvant chemotherapy (Arm B). The primary endpoint is overall survival, with secondary endpoints including R0 resection rate , disease-free survival and perioperative outcomes.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-07-04 | N/A | 2025-08-24 |
2025-07-22 | N/A | 2025-08-29 |
2025-07-23 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Neoadjuvant chemotherapy group (mFOLFIRINOX) Neoadjuvant chemotherapy(mFOLFIRINOX) followed by pancreaticoduodenectomy | DRUG: Neoadjuvant chemotherapy
|
| ACTIVE_COMPARATOR: Upfront Surgery Group Pancreaticoduodenectomy followed by adjuvant chemotherapy | PROCEDURE: Upfront Surgery Group
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Disease-free survival will be measured as the time between date of surgery and date of disease recurrence | Up to 3 years post-procedure. |
| Local recurrence rate | Local recurrence is defined as recurrence in the pancreatic resection margin, residual pancreas, and regional lymph nodes.The local recurrence is defined as the percentage of patients who had recurrence after the surgical resection. | Up to 3 years post-procedure. |
| Recurrence rate | The proportion of patients who experienced recurrence within 3 years from the date of surgery. | Up to 3 years post-procedure. |
| Time to locoregional recurrence (TLR) | Time to locoregional recurrence (TLR) is defined as the time from date of surgery to the date of locoregional recurrence after resection. | Up to 3 years post-procedure. |
| Response rate in neoadjuvant setting | Defined as the percentage of patients who showed complete response, partial response, and stable disease after the scheduled neoadjuvant chemotherapy. The evaluation is based on RECIST v.1.1. | 12 to 16 weeks. |
| Time to distant metastases (TDM) | Time to distant metastases (TDM) is defined as the time from randomization to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection. | Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 3 years. |
| Resection rate | Referred to the proportion of patients who underwent curative resection | At time of surgery or planned time of surgery. |
| R0 resection rate | The percentage of patients that underwent a microscopically margin-negative (R0) resection. The resection is considered R0 if there is no tumor within 1 mm of the margins. | One to two weeks postsurgery. |
| Lymph node-negative (N0) resection rate | The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen. | One to two weeks postsurgery. |
| Pathologic complete response (pCR) rate | The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen. | One to two weeks postsurgery. |
| Biomarker Response during neoadjuvant chemotherapy . | Carbohydrate antigen (CA) 19-9 levels predictive of response to neoadjuvant chemotherapy . | Baseline level is measured before start of neoadjuvant chemotherapy( within 1 week) , then after neoadjuvant therapy completion( 12 to 16 weeks). |
| Rate of unresectability | The rate (percentage) of patients who cannot undergo surgery due to adverse events, progressive disease, death, poor performance, or patient/physician decision, are deemed unresectable before surgery, or resection was not performed during surgery. | At time of surgery or planned time of surgery. |
| Chemotherapy start rate | The percentage of patients who received at least one cycle of scheduled chemotherapy. | upto 4 months. |
| Number of chemotherapy cycles received. | The number of scheduled chemotherapy cycles that patients received. | up to 4 months. |
| Chemotherapy completion rate | The percentage of patients who completed all cycles of scheduled chemotherapy. | up to 4 months. |
| Perioperative Complications | The specific postoperative complications of pancreatic surgery include postoperative pancreatic fistula, postoperative hemorrhage ,bile leak and gastroparesis. Other common postoperative complications include abdominal infection, incision nonunion and so on. | From surgery until 90 days post-surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Saleh K Saleh, MD Phone Number: +201201765401 Email: salehkhairy@mu.edu.eg |
Study Contact Backup Name: Rabeh K Saleh, MD Phone Number: +201220065443 Email: Rabeh.Saleh@mu.edu.eg |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
