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2025-02-01
2026-02-01
2026-02-01
30
NCT06978322
Minia University
Minia University
OBSERVATIONAL
Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer
This trial aimed to determine whether neoadjuvant chemoradiotherapy improves overall survival compared with upfront surgery, both followed by adjuvant chemotherapy in patients with resectable and borderline resectable pancreatic cancer.
Pancreatic cancer is one of the solid cancers with the poorest treatment outcomes, and there is an urgent need to improve its treatment outcomes. Among these, resectable pancreatic cancer is known to show relatively good treatment outcomes with surgical resection, but the 5-year survival rate is still about 20%, which is still unsatisfactory. Neoadjuvant therapy may increase the proportion of patients that actually receive chemotherapy and thereby improve survival. Furthermore, neoadjuvant therapy may increase the microscopically margin-negative (R0) resection rate and may identify patients with rapidly progressive disease who can be spared futile surgery.
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 |
|---|---|---|
2025-05-10 | N/A | 2025-05-10 |
2025-05-10 | N/A | 2025-05-18 |
2025-05-18 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Immediate surgery group Patients will undergo upfront surgery, then adjuvant chemotherapy. | PROCEDURE: Immediate surgery
|
| : Neoadjuvant chemotherapy group Patients will undergo neoadjuvant chemotherapy, then surgery. | PROCEDURE: Neoadjuvant chemotherapy
|
| 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. | 1 year post-procedure |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Achieve of R0 Resection | Resection is defined as the number of patients with an R0 resection margin. R0 resection margin rate will be measured according to the Africa Regional Collaborative Platform (RCP) report on standards and datasets for reporting cancers. | 1 year post-procedure |
| Disease free survival | Disease-free survival will be measured as the time between date of surgery and date of disease recurrence. | 1 year post-procedure |
| Time to locoregional recurrence | Time to locoregional recurrence will be recorded. | 1 year post-procedure |
| Time to distant metastasis | Time to distant metastasis will be recorded. | 1 year post-procedure |
| Incidence of postoperative complications | Incidence of postoperative complications such as hemorrhage and pancreatic fistula will be recorded. | 1 year post-procedure |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Abdelrahman M Salah, MD Phone Number: 00201064746493 Email: Abdelrahman.salah@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
No publications available
