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Pancreas CancerPhase 3NCT07081360

Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

A Phase 3 study testing Neoadjuvant chemotherapy and Upfront Surgery Group in people with Pancreas Cancer and Periampullary Cancer, run by Minia University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Neoadjuvant chemotherapy and Upfront Surgery Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteEgypt
Study dates
20 Jul 2025to 20 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).
  • Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging:
  • No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery .
  • Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence No evidence of metastatic disease.
  • Eastern Cooperative Oncology Group (ECOG)=0-1 \& American Society of Anesthesiologists (ASA) score <4.
  • Written informed consent.
  • Medical history without previous pancreatic resection or pancreatic cancer.
  • Adequate organ function (liver, kidney, bone marrow) (serum creatinine ≤2.0 mg/dL,reference range 0.5-1.20 mg/dL; serum albumin ≥2.5 g/dL, reference range 3.5-5.3; aspartate aminotransferase (AST) ≤95 U/L, reference range 0-38; Alanine aminotransferase (ALT) ≤102 U/L, reference range 0-41; prothrombin time ≤1.8, reference range 0-1.20; partial thromboplastin time ≤1.8, reference range 0.82-1.25; leukocyte count greater than 3.5×109/L, reference range 4.2-9.0; platelet count greater than 100×109/L, reference range 130-400; hemoglobin ≥9 g/dL, reference range 12-16).

Who cannot join

  • Borderline resectable or locally advanced pancreatic or periampullary cancer.
  • Tumor at the body or tail of the pancreas.
  • Distant metastases.
  • Prior chemotherapy , surgery or radiotherapy for pancreatic cancer.
  • Severe comorbidities precluding surgery or chemotherapy.
  • Pregnancy or lactation.
  • Other neoplastic diseases (malignant)diagnosed in the past 5 years.
  • Major surgery or traumatic event in the past 28 days.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saleh K Saleh, MD contact

+201201765401 ext. +2

salehkhairy@mu.edu.eg

Rabeh K Saleh, MD contact

+201220065443 ext. +2

Rabeh.Saleh@mu.edu.eg

Egypt1 site, 1 recruiting

  • Liver and GIT hospital , Minia University

    Minya, Minya Governorate, 61519

    Saleh K Saleh, 01201765401 ext. +2, salehkhairy@mu.edu.eg

    Sara T Boshra, MD

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the detailed description

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.

Being tested
Neoadjuvant chemotherapy, Upfront Surgery Group
Keywords
Pancreatic cancer, Neoadjuvant chemotherapy, Pancreaticoduodenectomy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant chemotherapyDrug

    Neoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy

  • Upfront Surgery GroupProcedure or surgery

    Pancreaticoduodenectomy followed by adjuvant chemotherapy

Study groups in NCT07081360
Study groupRoleWhat they receive
Neoadjuvant chemotherapy group (mFOLFIRINOX)ExperimentalNeoadjuvant chemotherapy(mFOLFIRINOX) followed by pancreaticoduodenectomy
Receives: Drug: Neoadjuvant chemotherapy
Upfront Surgery GroupActive comparatorPancreaticoduodenectomy followed by adjuvant chemotherapy
Receives: Procedure: Upfront Surgery Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Up to 3 years.

Secondary outcomes (16)

  1. Disease-free survival (DFS)

    Disease-free survival will be measured as the time between date of surgery and date of disease recurrence

    Measured: Up to 3 years post-procedure.

  2. 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.

    Measured: Up to 3 years post-procedure.

  3. Recurrence rate

    The proportion of patients who experienced recurrence within 3 years from the date of surgery.

    Measured: Up to 3 years post-procedure.

  4. 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.

    Measured: Up to 3 years post-procedure.

  5. 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.

    Measured: 12 to 16 weeks.

  6. 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.

    Measured: Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 3 years.

  7. Resection rate

    Referred to the proportion of patients who underwent curative resection

    Measured: At time of surgery or planned time of surgery.

  8. 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.

    Measured: One to two weeks postsurgery.

  9. Lymph node-negative (N0) resection rate

    The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen.

    Measured: One to two weeks postsurgery.

  10. 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.

    Measured: One to two weeks postsurgery.

  11. Biomarker Response during neoadjuvant chemotherapy .

    Carbohydrate antigen (CA) 19-9 levels predictive of response to neoadjuvant chemotherapy .

    Measured: Baseline level is measured before start of neoadjuvant chemotherapy( within 1 week) , then after neoadjuvant therapy completion( 12 to 16 weeks).

  12. 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.

    Measured: At time of surgery or planned time of surgery.

  13. Chemotherapy start rate

    The percentage of patients who received at least one cycle of scheduled chemotherapy.

    Measured: upto 4 months.

  14. Number of chemotherapy cycles received.

    The number of scheduled chemotherapy cycles that patients received.

    Measured: up to 4 months.

  15. Chemotherapy completion rate

    The percentage of patients who completed all cycles of scheduled chemotherapy.

    Measured: up to 4 months.

  16. 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.

    Measured: From surgery until 90 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start20 Jul 2025
  3. Primary completion20 Jul 2028 (estimated)
  4. Study completion20 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel groups: neoadjuvant chemotherapy followed by surgery versus upfront surgery
Masking
None (open label)
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07081360
Sponsor's protocol ID
1563/06/2025
Status last verified
Sep 2026
First submitted
4 Jul 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Evans DB. The Complexity of Neoadjuvant Therapy for Operable Pancreatic Cancer: Lessons Learned From SWOG S1505. Ann Surg. 2020 Sep 1;272(3):487. doi: 10.1097/SLA.0000000000004131. No abstract available.

    PubMed 32657915

  • Murphy JE, Wo JY, Ryan DP, Jiang W, Yeap BY, Drapek LC, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Faris JE, Zhu AX, Goyal L, Lillemoe KD, DeLaney TF, Fernandez-Del Castillo C, Ferrone CR, Hong TS. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):963-969. doi: 10.1001/jamaoncol.2018.0329.

    PubMed 29800971

  • Golcher H, Brunner TB, Witzigmann H, Marti L, Bechstein WO, Bruns C, Jungnickel H, Schreiber S, Grabenbauer GG, Meyer T, Merkel S, Fietkau R, Hohenberger W. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer: results of the first prospective randomized phase II trial. Strahlenther Onkol. 2015 Jan;191(1):7-16. doi: 10.1007/s00066-014-0737-7. Epub 2014 Sep 25.

    PubMed 25252602

  • Casadei R, Di Marco M, Ricci C, Santini D, Serra C, Calculli L, D'Ambra M, Guido A, Morselli-Labate AM, Minni F. Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets. J Gastrointest Surg. 2015 Oct;19(10):1802-12. doi: 10.1007/s11605-015-2890-4. Epub 2015 Jul 30.

    PubMed 26224039

  • Goetze TO, Reichart A, Bankstahl US, Pauligk C, Loose M, Kraus TW, Elshafei M, Bechstein WO, Trojan J, Behrend M, Homann N, Venerito M, Bohle W, Varvenne M, Bolling C, Behringer DM, Kratz-Albers K, Siegler GM, Hozaeel W, Al-Batran SE. Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter Phase II NEPAFOX Trial. Ann Surg Oncol. 2024 Jun;31(6):4073-4083. doi: 10.1245/s10434-024-15011-7. Epub 2024 Mar 8.

    PubMed 38459418

  • Gillen S, Schuster T, Meyer Zum Buschenfelde C, Friess H, Kleeff J. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010 Apr 20;7(4):e1000267. doi: 10.1371/journal.pmed.1000267.

    PubMed 20422030

  • Artinyan A, Anaya DA, McKenzie S, Ellenhorn JD, Kim J. Neoadjuvant therapy is associated with improved survival in resectable pancreatic adenocarcinoma. Cancer. 2011 May 15;117(10):2044-9. doi: 10.1002/cncr.25763. Epub 2010 Nov 18.

    PubMed 21523715

  • Mokdad AA, Minter RM, Zhu H, Augustine MM, Porembka MR, Wang SC, Yopp AC, Mansour JC, Choti MA, Polanco PM. Neoadjuvant Therapy Followed by Resection Versus Upfront Resection for Resectable Pancreatic Cancer: A Propensity Score Matched Analysis. J Clin Oncol. 2017 Feb 10;35(5):515-522. doi: 10.1200/JCO.2016.68.5081. Epub 2016 Sep 30.

    PubMed 27621388

  • Lee YS, Lee JC, Yang SY, Kim J, Hwang JH. Neoadjuvant therapy versus upfront surgery in resectable pancreatic cancer according to intention-to-treat and per-protocol analysis: A systematic review and meta-analysis. Sci Rep. 2019 Oct 30;9(1):15662. doi: 10.1038/s41598-019-52167-9.

    PubMed 31666626

  • Bradley A, Van Der Meer R. Upfront Surgery versus Neoadjuvant Therapy for Resectable Pancreatic Cancer: Systematic Review and Bayesian Network Meta-analysis. Sci Rep. 2019 Mar 13;9(1):4354. doi: 10.1038/s41598-019-40951-6.

    PubMed 30867522

  • Ye M, Zhang Q, Chen Y, Fu Q, Li X, Bai X, Liang T. Neoadjuvant chemotherapy for primary resectable pancreatic cancer: a systematic review and meta-analysis. HPB (Oxford). 2020 Jun;22(6):821-832. doi: 10.1016/j.hpb.2020.01.001. Epub 2020 Jan 27.

    PubMed 32001139

  • Adam MA, Nassour I, Hoehn R, Hlavin CA, Bahary N, Bartlett DL, Lee KKW, Zureikat AH, Paniccia A. Neoadjuvant Chemotherapy for Pancreatic Adenocarcinoma Lessens the Deleterious Effect of Omission of Adjuvant Chemotherapy. Ann Surg Oncol. 2021 Jul;28(7):3800-3807. doi: 10.1245/s10434-020-09446-x. Epub 2021 Jan 1.

    PubMed 33386547

  • Birrer DL, Golcher H, Casadei R, Haile SR, Fritsch R, Hussung S, Brunner TB, Fietkau R, Meyer T, Grutzmann R, Merkel S, Ricci C, Ingaldi C, Di Marco M, Guido A, Serra C, Minni F, Pestalozzi B, Petrowsky H, DeOliveira M, Bechstein WO, Bruns CJ, Oberkofler CE, Puhan M, Lesurtel M, Heinrich S, Clavien PA. Neoadjuvant Therapy for Resectable Pancreatic Cancer: A New Standard of Care. Pooled Data From 3 Randomized Controlled Trials. Ann Surg. 2021 Nov 1;274(5):713-720. doi: 10.1097/SLA.0000000000005126.

    PubMed 34334656

  • Ghanem I, Lora D, Herradon N, de Velasco G, Carretero-Gonzalez A, Jimenez-Varas MA, Vazquez de Parga P, Feliu J. Neoadjuvant chemotherapy with or without radiotherapy versus upfront surgery for resectable pancreatic adenocarcinoma: a meta-analysis of randomized clinical trials. ESMO Open. 2022 Jun;7(3):100485. doi: 10.1016/j.esmoop.2022.100485. Epub 2022 May 14.

    PubMed 35580504

  • van Dam JL, Janssen QP, Besselink MG, Homs MYV, van Santvoort HC, van Tienhoven G, de Wilde RF, Wilmink JW, van Eijck CHJ, Groot Koerkamp B; Dutch Pancreatic Cancer Group. Neoadjuvant therapy or upfront surgery for resectable and borderline resectable pancreatic cancer: A meta-analysis of randomised controlled trials. Eur J Cancer. 2022 Jan;160:140-149. doi: 10.1016/j.ejca.2021.10.023. Epub 2021 Nov 24.

    PubMed 34838371

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant chemotherapy and Upfront Surgery Group in people with Pancreas Cancer and Periampullary Cancer, 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Sep 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saleh K Saleh, MD (+201201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate (time frame: Up to 3 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07081360, which also lists 22 linked publications.

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 11 Sep 2026.

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