Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT00490360
Status:
COMPLETED
Last Update Posted:
2007-06-22
First Post:
2007-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2007}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-21', 'studyFirstSubmitDate': '2007-06-21', 'studyFirstSubmitQcDate': '2007-06-21', 'lastUpdatePostDateStruct': {'date': '2007-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resectability rate > 70% after restaging', 'timeFrame': '2007'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer of the Pancreatic Head']}, 'referencesModule': {'references': [{'pmid': '19092346', 'type': 'DERIVED', 'citation': 'Heinrich S, Schafer M, Weber A, Hany TF, Bhure U, Pestalozzi BC, Clavien PA. Neoadjuvant chemotherapy generates a significant tumor response in resectable pancreatic cancer without increasing morbidity: results of a prospective phase II trial. Ann Surg. 2008 Dec;248(6):1014-22. doi: 10.1097/SLA.0b013e318190a6da.'}]}, 'descriptionModule': {'briefSummary': 'Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.', 'detailedDescription': 'Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.\n\nStaging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.\n\n* Trial with medicinal product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria: - Age \\> 18 years\n\n* Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head\n* WHO-performance status 0-2\n* Written informed consent\n* Discussion in an intrdisciplinary conference\n\nExclusion criteria: - Insufficient renal function (calculated creatinin clearance \\< 60ml(min)\n\n* Insufficient hematologic function (neutrophil count \\<1'000/ul, platelets \\< 100'000/ul)\n* Uncorrectable coagulopathy\n* Severe cholestasis (bilirubin \\>100mmol/l)\n* Distant metastases in liver, lungs or other organs\n* Peritoneal carcinomatosis\n* Unresectable tumor (s. 4.2.)\n* Contraindication for Whipple procedure\n* Uncontrolled infection\n* Neurotphil count \\> °2\n* Estimated life experience \\< 6 months\n* HIV Infection\n* Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent\n* Female patients in child-bearing age without adequate contraception"}, 'identificationModule': {'nctId': 'NCT00490360', 'briefTitle': 'Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head', 'orgStudyIdInfo': {'id': '21-2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gemcitabine / Cisplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital of Zurich, Department of Surgery', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}}}}