Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-24 @ 6:13 AM
Study NCT ID:
NCT02626520
Status:
TERMINATED
Last Update Posted:
2018-11-13
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla
Sponsor:
Organization:
Raw JSON
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{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bret.friday@essentiahealth.org', 'phone': '218-786-3625', 'title': 'Dr. Bret Friday', 'organization': 'Essentia Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Study enrollment through study termination, on average approximately 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Resectable, Low Risk', 'description': 'Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\nDefinitive resection: Definitive surgical resection of primary tumor', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resectable, Low Risk', 'description': 'Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\nDefinitive resection: Definitive surgical resection of primary tumor'}, {'id': 'OG001', 'title': 'Locally Advanced', 'description': 'Systemic chemotherapy followed by chemoradiation, followed by definitive surgery\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\n5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles\n\nPreoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions\n\nDefinitive resection: Definitive surgical resection of primary tumor'}], 'timeFrame': '1 yr form onset of treatment', 'description': 'Percentage of patients alive and free of detectable disease 1 yr from start of treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to excessive toxicity of study regimen, the study was permanently closed prior to data analysis.'}, {'type': 'SECONDARY', 'title': 'R-0 Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resectable, Low Risk', 'description': 'Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\nDefinitive resection: Definitive surgical resection of primary tumor'}, {'id': 'OG001', 'title': 'Locally Advanced', 'description': 'Systemic chemotherapy followed by chemoradiation, followed by definitive surgery\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\n5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles\n\nPreoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions\n\nDefinitive resection: Definitive surgical resection of primary tumor'}], 'timeFrame': 'Time of surgery', 'description': 'Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected, study Terminated'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resectable, Low Risk', 'description': 'Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.\n\nGemcitabine and nanoparticle albumin bound 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followed by definitive surgery without pre-operative or post-operative radiotherapy.\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\nDefinitive resection: Definitive surgical resection of primary tumor'}, {'id': 'FG001', 'title': 'Locally Advanced', 'description': 'Systemic chemotherapy followed by chemoradiation, followed by definitive surgery\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\n5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles\n\nPreoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions\n\nDefinitive resection: Definitive surgical resection of primary tumor'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did not start protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Resectable, Low Risk', 'description': 'Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\nDefinitive resection: Definitive surgical resection of primary tumor'}, {'id': 'BG001', 'title': 'Locally Advanced', 'description': 'Systemic chemotherapy followed by chemoradiation, followed by definitive surgery\n\nGemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles\n\n5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles\n\nPreoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions\n\nDefinitive resection: Definitive surgical resection of primary tumor'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '64', 'upperLimit': '64'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '80'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Study team felt toxicity of study regimen outweighed potential benefit.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2015-12-03', 'resultsFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-12', 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse Free Survival', 'timeFrame': '1 yr form onset of treatment', 'description': 'Percentage of patients alive and free of detectable disease 1 yr from start of treatment'}], 'secondaryOutcomes': [{'measure': 'R-0 Rate', 'timeFrame': 'Time of surgery', 'description': 'Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 3 years from registration', 'description': 'Time to death from any cause measured from start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ductal Adenocarcinoma of Pancreas', 'Adenocarcinoma of Ampulla']}, 'referencesModule': {'availIpds': [{'url': 'https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxyZWFsd29ybGRvbmNvbG9neXxneDo2OGI0ZDgxMzdkZDIxYWJh', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.', 'detailedDescription': 'Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).\n\nAll patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.\n\nAll patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \\& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.\n\nAfter approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.\n\nAdjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.\n\nPatients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.\n* Fitness for chemotherapy in judgement of treating physician\n* Bilirubin \\< 4 (any means of biliary drainage acceptable)\n\nExclusion Criteria:\n\n* Medical or mental illness precluding provision of informed consent\n* Pregnancy\n* Active infection for which neutropenia would pose high risk of mortality'}, 'identificationModule': {'nctId': 'NCT02626520', 'briefTitle': 'Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla', 'organization': {'class': 'OTHER', 'fullName': 'Essentia Health'}, 'officialTitle': 'Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla', 'orgStudyIdInfo': {'id': 'PANC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resectable, Low Risk', 'description': 'Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.', 'interventionNames': ['Drug: Gemcitabine and nanoparticle albumin bound paclitaxel', 'Procedure: Definitive resection']}, {'type': 'EXPERIMENTAL', 'label': 'Locally Advanced', 'description': 'Systemic chemotherapy followed by chemoradiation, followed by definitive surgery', 'interventionNames': ['Drug: Gemcitabine and nanoparticle albumin bound paclitaxel', 'Drug: 5-fluorouracil and irinotecan', 'Radiation: Preoperative chemoradiation', 'Procedure: Definitive resection']}], 'interventions': [{'name': 'Gemcitabine and nanoparticle albumin bound paclitaxel', 'type': 'DRUG', 'otherNames': ['Gem/Abraxane, Gemcitabine/nab-paclitaxel'], 'description': 'Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles', 'armGroupLabels': ['Locally Advanced', 'Resectable, Low Risk']}, {'name': '5-fluorouracil and irinotecan', 'type': 'DRUG', 'otherNames': ['FOLFIRI.3, FOLFIRI-3'], 'description': 'FOLFIRI.3 given every 14 days x 4 cycles', 'armGroupLabels': ['Locally Advanced']}, {'name': 'Preoperative chemoradiation', 'type': 'RADIATION', 'description': 'Pre-operative chemoradiation to 40 Gy in 20 fractions', 'armGroupLabels': ['Locally Advanced']}, {'name': 'Definitive resection', 'type': 'PROCEDURE', 'otherNames': ['pancreaticoduodenectomy, Whipple procedure'], 'description': 'Definitive surgical resection of primary tumor', 'armGroupLabels': ['Locally Advanced', 'Resectable, Low Risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health Cancer Center', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}], 'overallOfficials': [{'name': 'Peter Kebbekus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Essentia Health Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We will make unidentified dataset available for electronic download.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essentia Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}