Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-04-24 @ 5:00 AM
Study NCT ID:
NCT01521702
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': 'from date of randomization until date of progression, assessed up to 5 years', 'description': 'period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).'}], 'secondaryOutcomes': [{'measure': 'histology', 'timeFrame': 'at 6 months', 'description': 'histological response,'}, {'measure': 'overall survival', 'timeFrame': 'From date of randomization until date of death, assessed up to 5 years', 'description': 'time from date of inclusion to date of death'}, {'measure': 'complication', 'timeFrame': 'until 6 months', 'description': 'complication rates after surgery,'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma', 'pancreatic head'], 'conditions': ['Pancreas Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr', 'label': 'official web site of the sponsor'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).\n\nThis study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)\n* T1-3, Nx, M0 (UICC 6th version, 2002)\n* infiltration of the portal vein (\\<180°) is not an exclusion criterion\n* cytologic or histologic confirmation of adenocarcinoma\n* age \\>18 years\n* written informed consent\n\nExclusion Criteria:\n\n* contraindication for Whipple procedure\n* an infiltration \\>180° of the portal vein\n* abutment of the tumor to the superior mesenteric artery\n* infiltration of the superior mesenteric artery or the celiac trunk\n* chronic neuropathy \\> grade 2\n* WHO performance score \\>2\n* uncorrectable cholestasis (bilirubin \\> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)\n* female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)\n* pregnant or lactating women\n* mental or organic disorders which could interfere with giving informed consent or receiving treatments\n* Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer\n* percutaneous biopsy of the primary tumor'}, 'identificationModule': {'nctId': 'NCT01521702', 'acronym': 'NEOPAC', 'briefTitle': 'NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study', 'orgStudyIdInfo': {'id': 'NEOPAC / IPC 2011-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant chemotherapy', 'description': 'After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11).', 'interventionNames': ['Drug: Neoadjuvant chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surgery', 'description': 'surgery', 'interventionNames': ['Procedure: surgery and Adjuvant chemotherapy']}], 'interventions': [{'name': 'Neoadjuvant chemotherapy', 'type': 'DRUG', 'description': 'four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,', 'armGroupLabels': ['Neoadjuvant chemotherapy']}, {'name': 'surgery and Adjuvant chemotherapy', 'type': 'PROCEDURE', 'description': 'surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.', 'armGroupLabels': ['surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jean-Luc RAOUL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}