Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT01628458
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2012-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic 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': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-29', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-06-22', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Within 30 days after the RFA procedure', 'description': 'The safety will be specified as the percentage of patients with complications directly related to RFA and the routinely performed double-bypass procedure, requiring re-intervention (i.e. endoscopy, radiology, or surgery). This is also known as a complication of grade III or higher in the Clavien-Dindo classification (internationally accepted classification for surgical complications). Moreover all in-hospital complications or complications developed within 30 days after the RFA procedure will be evaluated according to the Clavien-Dindo classification.'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': '2 years after RFA procedure'}, {'measure': 'VAS pain score', 'timeFrame': '3 months'}, {'measure': 'length hospital stay', 'timeFrame': '3 months'}, {'measure': 'progression free survival', 'timeFrame': '2 years after RFA procedure'}, {'measure': 'CA19-9 response', 'timeFrame': '2 years after RFA procedure'}, {'measure': 'Chemotherapy', 'timeFrame': '2 years', 'description': 'Type, frequency, dosage and duration of chemotherapy will be registered.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'locally advanced', 'irresectable', 'Radiofrequency', 'RFA'], 'conditions': ['Locally Advanced Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '22648697', 'type': 'BACKGROUND', 'citation': 'Cantore M, Girelli R, Mambrini A, Frigerio I, Boz G, Salvia R, Giardino A, Orlandi M, Auriemma A, Bassi C. Combined modality treatment for patients with locally advanced pancreatic adenocarcinoma. Br J Surg. 2012 Aug;99(8):1083-8. doi: 10.1002/bjs.8789. Epub 2012 May 30.'}, {'pmid': '20069610', 'type': 'BACKGROUND', 'citation': 'Girelli R, Frigerio I, Salvia R, Barbi E, Tinazzi Martini P, Bassi C. Feasibility and safety of radiofrequency ablation for locally advanced pancreatic cancer. Br J Surg. 2010 Feb;97(2):220-5. doi: 10.1002/bjs.6800.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.', 'detailedDescription': 'Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients. Therefore, there is an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. RFA produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. The purpose of this study is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA\n2. Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht\n3. Fully informed written consent given\n\nExclusion Criteria:\n\n1. Patients younger than 18 years\n2. Pregnancy\n3. Patients with distant metastases\n4. Portal vein thrombosis seen on CT preoperatively'}, 'identificationModule': {'nctId': 'NCT01628458', 'acronym': 'RFA of LAPC', 'briefTitle': 'Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': '12-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'radiofrequency ablation', 'interventionNames': ['Procedure: radiofrequency ablation (RFA)']}], 'interventions': [{'name': 'radiofrequency ablation (RFA)', 'type': 'PROCEDURE', 'otherNames': ['CELON Power System, CE mark 0197'], 'description': 'RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.', 'armGroupLabels': ['radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Richard van Hillegersberg, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in surgery', 'investigatorFullName': 'R. van Hillegersberg', 'investigatorAffiliation': 'UMC Utrecht'}}}}