Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT06868693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Elderly with Pancreatic Head 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'}, {'id': 'C041665', 'term': 'N-acetyltalosaminuronic acid'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-08', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years from treatment initiation', 'description': 'OS is defined as the time from the initiation of treatment (NAT or upfront surgery) to death from any cause. Patients still alive at the end of the study period will be censored at the last follow-up date.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 1 years from treatment initiation', 'description': 'PFS is defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed based on RECIST v1.1 criteria using imaging studies.'}, {'measure': 'Resection Rate and R0 Resection Rate', 'timeFrame': 'At the time of surgery', 'description': 'The proportion of patients who successfully undergo surgical resection after NAT compared to upfront surgery. Resection margins will be classified as:\n\nR0 (complete resection, negative margins) R1 (microscopic residual disease) R2 (macroscopic residual disease)'}, {'measure': 'Major Toxicities and NAT Dropout Rate', 'timeFrame': 'At the end of each cycle (each cycle is 28 days)', 'description': 'Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The study will report grade 3-4 toxicities, dose reductions, treatment interruptions, and patient dropout rates due to adverse events.'}, {'measure': 'Conversion Rate of NAT in Borderline Resectable (BR) PDAC', 'timeFrame': 'At the time of surgery', 'description': 'The proportion of patients initially classified as borderline resectable (BR) who are successfully converted to resectable status after NAT and undergo curative-intent surgery.'}, {'measure': 'Vascular Resection Rate', 'timeFrame': 'At the time of surgery', 'description': 'Comparison of the frequency of vascular resections (e.g., portal vein or superior mesenteric vein resection) between the NAT and upfront surgery groups, assessing the impact of NAT on vascular involvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer Resectable', 'Pancreatic Cancer Stage II', 'Neoadjuvant Therapy', 'Elderly', 'Borderline Pancreatic Inoperable Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAT) in elderly patients with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). The study includes patients aged ≥70 years who have undergone NAT followed by surgery or upfront surgery.\n\nThe main questions it aims to answer are:\n\nDoes NAT improve overall survival (OS) and progression-free survival (PFS) in elderly patients compared to upfront surgery? What is the impact of NAT on R0 resection rates, conversion rates in BR tumors, and the need for vascular resection? How does the toxicity profile of different NAT regimens affect treatment outcomes and patient tolerability? Researchers will compare NAT followed by surgery vs. upfront surgery to determine differences in oncologic outcomes and postoperative complications.\n\nParticipants will:\n\nBe retrospectively identified from hospital records. Be classified based on treatment received (NAT vs. upfront surgery). Undergo data collection on tumor characteristics, treatment regimens, surgical details, and survival outcomes.\n\nThis study aims to refine patient selection criteria for NAT in elderly patients, guiding personalized treatment strategies to optimize survival and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of elderly patients (≥70 years old) diagnosed with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). Patients will be retrospectively identified from hospital databases and electronic medical records across multiple international and multicenter institutions.\n\nParticipants included in the study have undergone either neoadjuvant chemotherapy (NAT) followed by surgery or upfront surgery (pancreaticoduodenectomy). Data will be collected from oncology, surgery, and gastroenterology units within tertiary referral centers and high-volume pancreatic cancer treatment centers.\n\nThe study focuses on real-world clinical practice and aims to evaluate treatment outcomes, including overall survival, disease progression, surgical resection rates, and treatment-related toxicities, in this clinically vulnerable population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients aged ≥ 70 years\n* Patients with resectable or BR PDAC who underwent curative treatment (NAT followed by surgery and upfront surgery)\n* Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \\> 2\n* Patients able to provide informed consent, whenever possible\n\nExclusion Criteria\n\n* Patients not meeting the inclusion criteria.\n* Pancreatic cancer of pancreatic body and tail.\n* Patients with metastatic disease.\n* Patients with locally advanced or metastatic pancreatic cancer'}, 'identificationModule': {'nctId': 'NCT06868693', 'acronym': 'PEACE', 'briefTitle': 'Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Unita Sanitaria Locale di Piacenza'}, 'officialTitle': 'Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study', 'orgStudyIdInfo': {'id': 'PEACE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Upfront Surgery (UFS) Group', 'description': 'This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent upfront surgical resection (pancreaticoduodenectomy) without prior neoadjuvant therapy. The study will compare oncologic outcomes, including OS, PFS, R0 resection rates, and postoperative complications, between patients receiving NAT and those undergoing immediate surgery.', 'interventionNames': ['Drug: Neoadjuvant Chemotherapy (NAT) Group']}], 'interventions': [{'name': 'Neoadjuvant Chemotherapy (NAT) Group', 'type': 'DRUG', 'description': 'This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy (NAT). The NAT regimens include 5-FluoroUracil, Irinotecan, Oxaliplatin (FOLFIRINOX), gemcitabine/nab-paclitaxel (GnP), and other standard chemotherapy protocols. The study aims to evaluate the impact of NAT on overall survival (OS), progression-free survival (PFS), R0 resection rates, and postoperative outcomes, as well as the toxicity profile of different NAT regimens.', 'armGroupLabels': ['Upfront Surgery (UFS) Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mario Giuffrida, MD', 'role': 'CONTACT', 'email': 'mario.giuffrida4@gmail.com', 'phone': '+39 3931555684'}], 'overallOfficials': [{'name': 'Mario Giuffrida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUSL Piacenza'}, {'name': 'Elena Orlandi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUSL Piacenza'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Unita Sanitaria Locale di Piacenza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD (Doctor of Medicine)', 'investigatorFullName': 'Elena Orlandi', 'investigatorAffiliation': 'Azienda Unita Sanitaria Locale di Piacenza'}}}}