Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01419002
Status:
TERMINATED
Last Update Posted:
2015-07-29
First Post:
2011-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head 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': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016577', 'term': 'Pancreaticoduodenectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2011-08-13', 'studyFirstSubmitQcDate': '2011-08-16', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local recurrence free survival', 'timeFrame': 'At 12 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Percentage of surgical R0-resections in both groups', 'timeFrame': 'Until 10 days postoperative', 'description': 'Determined by histopathological analysis of the surgical specimen.'}, {'measure': '30-day morbidity and mortality', 'timeFrame': '30 day period after the operation'}, {'measure': 'Toxicity of preoperative Radiotherapy', 'timeFrame': 'Start of the radiotherapy until 12 months postoperative.', 'description': 'Number of patients with adverse events in both groups, number of adverse events in both groups and number of grade 3 and 4 adverse events according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) in both groups'}, {'measure': 'Clinical response rate (RECIST-criteria) and histological response rate', 'timeFrame': 'Until 1 year postOP'}, {'measure': 'Time to tumor progression (local and systemic)', 'timeFrame': 'Until 1 year postoperative'}, {'measure': 'Quality of life', 'timeFrame': 'Until 12 months postoperative'}, {'measure': 'Overall survival after 1 year', 'timeFrame': 'Until 1 year postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Adenocarcinoma', 'Neoadjuvant Radiotherapy'], 'conditions': ['Pancreatic Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://tumstrahlen.einzelportal.de/', 'label': 'Department of Radiation Oncology, Technische Universität München'}]}, 'descriptionModule': {'briefSummary': 'Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.', 'detailedDescription': 'The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the pancreatic head\n* Age ≥ 18 years\n* Signed informed consent\n* ECOG performance status of 0-2\n\nExclusion Criteria:\n\n* Curative resection is not feasible or presence of metastatic disease\n* Patients not eligible for surgery (ASA ≥ 4)\n* Participation in an other clinical trial\n* Unable or unwilling to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT01419002', 'acronym': 'Net-Pac', 'briefTitle': 'Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'CHIR-Net'}, 'officialTitle': 'Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial', 'orgStudyIdInfo': {'id': 'NetPac'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant RTx', 'interventionNames': ['Radiation: neoadjuvant RTx']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'neoadjuvant RTx', 'type': 'RADIATION', 'otherNames': ['Intensity modulated beam radiation (IMBR).'], 'description': 'Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.', 'armGroupLabels': ['Neoadjuvant RTx']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['Kausch-Whipple, Pancreaticoduodenectomy, ppWhipple'], 'description': 'Surgery and adjuvant chemotherapy according to German S3-guidelines', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Helmut M Friess, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}, {'name': 'Michael Molls, Prof. MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHIR-Net', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}