SurgeryNCT06978322
Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer
An observational study of Surgery and Neoadjuvant Chemotherapy, run by Minia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Neoadjuvant Chemotherapy, Management
- What is being tested?
- Immediate surgery and Neoadjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective and retrospective study will be conducted on 30 patients with resectable pancreatic cancer.
Who may be able to join
- Computed tomography (CT) with pancreatic protocol + vascular mapping
- Histopathologically proven malignant by CT-guided or endoscopic ultrasound (EUS)-guided biopsy Resectable pancreatic cancer means no contact of the tumor with the Superior mesenteric artery, Celiac axis \& Common hepatic artery, and contact of the tumor but ≤90° contact with the superior mesenteric vein \& portal vein.
Who cannot join
- Borderline resectable \& locally advanced pancreatic cancer
- Tumor at the tail of the pancreas.
- Metastatic pancreatic cancer
- Unfit patients for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Immediate surgery, Neoadjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate surgeryProcedure or surgery
Patients will undergo upfront surgery, then adjuvant chemotherapy.
Neoadjuvant chemotherapyProcedure or surgery
Patients will undergo neoadjuvant chemotherapy, then surgery.
| Study group | Role | What they receive |
|---|---|---|
| Immediate surgery group | Patients will undergo upfront surgery, then adjuvant chemotherapy. Receives: Procedure: Immediate surgery | |
| Neoadjuvant chemotherapy group | Patients will undergo neoadjuvant chemotherapy, then surgery. Receives: Procedure: Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post-procedure
Secondary outcomes (5)
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.
Measured: 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.
Measured: 1 year post-procedure
Time to locoregional recurrence
Time to locoregional recurrence will be recorded.
Measured: 1 year post-procedure
Time to distant metastasis
Time to distant metastasis will be recorded.
Measured: 1 year post-procedure
Incidence of postoperative complications
Incidence of postoperative complications such as hemorrhage and pancreatic fistula will be recorded.
Measured: 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Feb 2022
- Primary completion1 Feb 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Salah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978322
- Sponsor's protocol ID
- 1437/02/2025
- Status last verified
- Oct 2026
- First submitted
- 10 May 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06978322
- Acronym / sponsor ID
- 1437/02/2025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate surgery group | – | Procedure: Immediate surgeryPatients will undergo upfront surgery, then adjuvant chemotherapy. |
| Neoadjuvant chemotherapy group | – | Procedure: Neoadjuvant chemotherapyPatients will undergo neoadjuvant chemotherapy, then surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective and retrospective study will be conducted on 30 patients with resectable pancreatic cancer.
Key inclusion criteria (2 listed)
- Computed tomography (CT) with pancreatic protocol + vascular mapping
- Histopathologically proven malignant by CT-guided or endoscopic ultrasound (EUS)-guided biopsy Resectable pancreatic cancer means no contact of the tumor with the Superior mesenteric artery, Celiac axis \& Common hepatic artery, and contact of the tumor but ≤90° contact with the superior mesenteric vein \& portal vein.
Key exclusion criteria (4 listed)
- Borderline resectable \& locally advanced pancreatic cancer
- Tumor at the tail of the pancreas.
- Metastatic pancreatic cancer
- Unfit patients for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate surgeryPatients will undergo upfront surgery, then adjuvant chemotherapy. | Procedure or surgery | Immediate surgery group |
| Neoadjuvant chemotherapyPatients will undergo neoadjuvant chemotherapy, then surgery. | Procedure or surgery | Neoadjuvant chemotherapy group |
Primary outcome
Overall survival rate
Time frame: 1 year post-procedure
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.
5 secondary outcomes
Achieve of R0 Resection
Time frame: 1 year post-procedure
Disease free survival
Time frame: 1 year post-procedure
Time to locoregional recurrence
Time frame: 1 year post-procedure
Time to distant metastasis
Time frame: 1 year post-procedure
Incidence of postoperative complications
Time frame: 1 year post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Neoadjuvant Chemotherapy, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 1 year post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.