Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-03-14 @ 2:55 AM
Study NCT ID:
NCT01985958
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Edgar.Ben-Josef@uphs.upenn.edu', 'phone': '215-662-3932', 'title': 'Edgar Ben-Josef, M.D.', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.\n\nRadiation therapy', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.\n\nRadiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One Year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.\n\nRadiation therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.\n\nRadiation therapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '17.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2013-11-11', 'resultsFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-04', 'studyFirstPostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'One Year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Histological or Cytological Diagnosis of Pancreatic Carcinoma']}, 'descriptionModule': {'briefSummary': 'Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas.\n\nSecondary Objectives: To characterize the kinetics of an immune response induced by radiotherapy. To characterize the dependency of the immune response on prior exposure to chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of pancreatic carcinoma\n* Patients ≥ 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2\n* Patients must have distant metastatic disease (stage 4)\n* Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count\\> 1,000/uL, Platelets \\> 75,000uL Hemoglobin \\> 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,\n* Creatinine ≤ 1.5x the institutional normal upper limit\n* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit.\n* A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.\n* Must be able to provide informed consent.\n\nExclusion Criteria:\n\n* No prior radiation to the area planned for radiotherapy\n* Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level \\< 1.0 are not excluded.\n* Known HIV, HCV and/or HBV positive (by patient report/medical record)\n* Patients with ongoing or active infection\n* Planned concurrent treatment with systemic high dose corticosteroids.\n* Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.\n* Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.\n* Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.'}, 'identificationModule': {'nctId': 'NCT01985958', 'briefTitle': 'A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Pilot Study to Evaluate Radiotherapy-Induced Ant-Tumor Immunity in Metastatic Carcinoma of the Pancreas', 'orgStudyIdInfo': {'id': 'UPCC 14213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.', 'interventionNames': ['Device: Radiation therapy']}], 'interventions': [{'name': 'Radiation therapy', 'type': 'DEVICE', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Edgar Ben-Josef, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}