Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT07081360
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel groups: neoadjuvant chemotherapy followed by surgery versus upfront surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 262}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': 'Up to 3 years.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Up to 3 years post-procedure.', 'description': 'Disease-free survival will be measured as the time between date of surgery and date of disease recurrence'}, {'measure': 'Local recurrence rate', 'timeFrame': 'Up to 3 years post-procedure.', 'description': '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.'}, {'measure': 'Recurrence rate', 'timeFrame': 'Up to 3 years post-procedure.', 'description': 'The proportion of patients who experienced recurrence within 3 years from the date of surgery.'}, {'measure': 'Time to locoregional recurrence (TLR)', 'timeFrame': 'Up to 3 years post-procedure.', 'description': 'Time to locoregional recurrence (TLR) is defined as the time from date of surgery to the date of locoregional recurrence after resection.'}, {'measure': 'Response rate in neoadjuvant setting', 'timeFrame': '12 to 16 weeks.', 'description': '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.'}, {'measure': 'Time to distant metastases (TDM)', 'timeFrame': 'Time between randomization and metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection, assessed up to 3 years.', 'description': '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.'}, {'measure': 'Resection rate', 'timeFrame': 'At time of surgery or planned time of surgery.', 'description': 'Referred to the proportion of patients who underwent curative resection'}, {'measure': 'R0 resection rate', 'timeFrame': 'One to two weeks postsurgery.', 'description': '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.'}, {'measure': 'Lymph node-negative (N0) resection rate', 'timeFrame': 'One to two weeks postsurgery.', 'description': 'The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen.'}, {'measure': 'Pathologic complete response (pCR) rate', 'timeFrame': 'One to two weeks postsurgery.', 'description': 'The rate (percentage) of patients who achieve a pathologic complete response (pCR) confirmed by histopathologic review of the surgical specimen.'}, {'measure': 'Biomarker Response during neoadjuvant chemotherapy .', 'timeFrame': 'Baseline level is measured before start of neoadjuvant chemotherapy( within 1 week) , then after neoadjuvant therapy completion( 12 to 16 weeks).', 'description': 'Carbohydrate antigen (CA) 19-9 levels predictive of response to neoadjuvant chemotherapy .'}, {'measure': 'Rate of unresectability', 'timeFrame': 'At time of surgery or planned time of surgery.', 'description': '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.'}, {'measure': 'Chemotherapy start rate', 'timeFrame': 'upto 4 months.', 'description': 'The percentage of patients who received at least one cycle of scheduled chemotherapy.'}, {'measure': 'Number of chemotherapy cycles received.', 'timeFrame': 'up to 4 months.', 'description': 'The number of scheduled chemotherapy cycles that patients received.'}, {'measure': 'Chemotherapy completion rate', 'timeFrame': 'up to 4 months.', 'description': 'The percentage of patients who completed all cycles of scheduled chemotherapy.'}, {'measure': 'Perioperative Complications', 'timeFrame': 'From surgery until 90 days post-surgery', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'Neoadjuvant chemotherapy', 'Pancreaticoduodenectomy'], 'conditions': ['Pancreas Cancer', 'Periampullary Cancer', 'Periampullary Carcinoma Resectable', 'Pancreatic Cancer Resectable', 'Ampullary Cancer', 'Pancreas Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '32657915', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29800971', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25252602', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26224039', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '38459418', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20422030', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21523715', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27621388', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31666626', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30867522', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32001139', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33386547', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34334656', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35580504', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34838371', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32105518', 'type': 'BACKGROUND', 'citation': 'Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. doi: 10.1200/JCO.19.02274. Epub 2020 Feb 27.'}, {'pmid': '11331473', 'type': 'BACKGROUND', 'citation': 'Pingpank JF, Hoffman JP, Ross EA, Cooper HS, Meropol NJ, Freedman G, Pinover WH, LeVoyer TE, Sasson AR, Eisenberg BL. Effect of preoperative chemoradiotherapy on surgical margin status of resected adenocarcinoma of the head of the pancreas. J Gastrointest Surg. 2001 Mar-Apr;5(2):121-30. doi: 10.1016/s1091-255x(01)80023-8.'}, {'pmid': '11520088', 'type': 'BACKGROUND', 'citation': 'van Geenen RC, van Gulik TM, Offerhaus GJ, de Wit LT, Busch OR, Obertop H, Gouma DJ. Survival after pancreaticoduodenectomy for periampullary adenocarcinoma: an update. Eur J Surg Oncol. 2001 Sep;27(6):549-57. doi: 10.1053/ejso.2001.1162.'}, {'pmid': '30575490', 'type': 'BACKGROUND', 'citation': "Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775."}, {'pmid': '34514521', 'type': 'BACKGROUND', 'citation': 'Snyder RA, Parikh AA. Actual Survival in Patients with Resected Pancreatic Cancer: How Do Real-World Data Compare with Clinical Trial Evidence? Ann Surg Oncol. 2021 Dec;28(13):8014-8016. doi: 10.1245/s10434-021-10532-x. Epub 2021 Sep 12. No abstract available.'}, {'pmid': '37550634', 'type': 'BACKGROUND', 'citation': 'van Dam JL, Verkolf EMM, Dekker EN, Bonsing BA, Bratlie SO, Brosens LAA, Busch OR, van Driel LMJW, van Eijck CHJ, Feshtali S, Ghorbani P, de Groot DJA, de Groot JWB, Haberkorn BCM, de Hingh IH, van der Holt B, Karsten TM, van der Kolk MB, Labori KJ, Liem MSL, Loosveld OJL, Molenaar IQ, Polee MB, van Santvoort HC, de Vos-Geelen J, Wumkes ML, van Tienhoven G, Homs MYV, Besselink MG, Wilmink JW, Groot Koerkamp B; Dutch Pancreatic Cancer Group. Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial. BMC Cancer. 2023 Aug 7;23(1):728. doi: 10.1186/s12885-023-11141-5.'}, {'pmid': '38237621', 'type': 'BACKGROUND', 'citation': 'Labori KJ, Bratlie SO, Andersson B, Angelsen JH, Biorserud C, Bjornsson B, Bringeland EA, Elander N, Garresori H, Gronbech JE, Haux J, Hemmingsson O, Liljefors MG, Myklebust TA, Nymo LS, Peltola K, Pfeiffer P, Sallinen V, Sandstrom P, Sparrelid E, Stenvold H, Soreide K, Tingstedt B, Verbeke C, Ohlund D, Klint L, Dueland S, Lassen K; Nordic Pancreatic Cancer Trial-1 study group. Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):205-217. doi: 10.1016/S2468-1253(23)00405-3. Epub 2024 Jan 15.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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.\n\nThis 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.', 'detailedDescription': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).\n* Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging:\n\nNo involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery .\n\nLess 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.\n\n* Eastern Cooperative Oncology Group (ECOG)=0-1 \\& American Society of Anesthesiologists (ASA) score \\<4.\n* Written informed consent.\n* Medical history without previous pancreatic resection or pancreatic cancer.\n* 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).\n\nExclusion Criteria:\n\n* Borderline resectable or locally advanced pancreatic or periampullary cancer.\n* Tumor at the body or tail of the pancreas.\n* Distant metastases.\n* Prior chemotherapy , surgery or radiotherapy for pancreatic cancer.\n* Severe comorbidities precluding surgery or chemotherapy.\n* Pregnancy or lactation.\n* Other neoplastic diseases (malignant)diagnosed in the past 5 years.\n* Major surgery or traumatic event in the past 28 days.'}, 'identificationModule': {'nctId': 'NCT07081360', 'briefTitle': 'Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1563/06/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant chemotherapy group (mFOLFIRINOX)', 'description': 'Neoadjuvant chemotherapy(mFOLFIRINOX) followed by pancreaticoduodenectomy', 'interventionNames': ['Drug: Neoadjuvant chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Upfront Surgery Group', 'description': 'Pancreaticoduodenectomy followed by adjuvant chemotherapy', 'interventionNames': ['Procedure: Upfront Surgery Group']}], 'interventions': [{'name': 'Neoadjuvant chemotherapy', 'type': 'DRUG', 'description': 'Neoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy', 'armGroupLabels': ['Neoadjuvant chemotherapy group (mFOLFIRINOX)']}, {'name': 'Upfront Surgery Group', 'type': 'PROCEDURE', 'description': 'Pancreaticoduodenectomy followed by adjuvant chemotherapy', 'armGroupLabels': ['Upfront Surgery Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61519', 'city': 'Minya', 'state': 'Minya Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Saleh K Saleh', 'role': 'CONTACT', 'email': 'salehkhairy@mu.edu.eg', 'phone': '01201765401', 'phoneExt': '+2'}, {'name': 'Sara T Boshra, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Liver and GIT hospital , Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Saleh K Saleh, MD', 'role': 'CONTACT', 'email': 'salehkhairy@mu.edu.eg', 'phone': '+201201765401', 'phoneExt': '+2'}, {'name': 'Rabeh K Saleh, MD', 'role': 'CONTACT', 'email': 'Rabeh.Saleh@mu.edu.eg', 'phone': '+201220065443', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Saleh K Saleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Saleh Khairy Saleh MD', 'investigatorAffiliation': 'Minia University'}}}}