Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT00178256
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yuhchyau_chen@urmc.rochester.edu', 'phone': '585-275-5575', 'title': 'Yuhchyau Chen MD, PhD', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Subjects Enrolled', 'otherNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 41, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'NCI CTCAE v.4'}, {'term': 'Adult Respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'community acquired pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v.4'}, {'term': 'Thromboembolic event', 'notes': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v.4'}, {'term': 'bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v.4'}, {'term': 'Myelodysplastic syndrome', 'notes': 'Pathology showed this to be unrelated to the chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v.4'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1st Dose Cohort 15mg/m2 Taxol Plus RT', 'description': '15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nOn Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible\n\nPaclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nRadiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible'}, {'id': 'OG001', 'title': '2nd Dose cohort20 mg/m2 Taxol Plus Daily RT', 'description': 'Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nRadiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible'}, {'id': 'OG002', 'title': '3rd Dose Cohort --25mg/m2 Taxol Plus RT', 'description': 'Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nRadiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'unitOfMeasure': 'Percentage subj w dose limiting toxicity', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Pts Enrolled Daily RT Plus Chemo on MWF', 'description': 'Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nOn Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible\n\nRadiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible\n\nPaclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '85.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '86 months', 'description': 'This is median survival for all subjects enrolled.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT', 'description': 'On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.\n\nA minimum of three patients will be assigned at each dose level.\n\nIf no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.\n\nIf one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.\n\nDose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT'}, {'id': 'FG001', 'title': 'Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT', 'description': 'On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.\n\nA minimum of three patients will be assigned at each dose level.\n\nIf no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.\n\nIf one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.\n\nDose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT'}, {'id': 'FG002', 'title': 'Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT', 'description': 'A minimum of three patients will be assigned at each dose level.\n\nIf no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.\n\nIf one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.\n\nDose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT'}, {'id': 'FG003', 'title': 'Phase II Group (20mg/m2 Taxol)', 'description': 'Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate.\n\nIf four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Cancer progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Daily RT Plus Chemo on MWF', 'description': 'Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nOn Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible\n\nRadiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible\n\nPaclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-11', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Median Survival', 'timeFrame': '86 months', 'description': 'This is median survival for all subjects enrolled.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '12631594', 'type': 'RESULT', 'citation': 'Chen Y, Pandya K, Keng PC, Johnstone D, Li J, Lee YJ, Smudzin T, Okunieff P. Phase I/II clinical study of pulsed paclitaxel radiosensitization for thoracic malignancy: a therapeutic approach on the basis of preclinical research of human cancer cell lines. Clin Cancer Res. 2003 Mar;9(3):969-75.'}]}, 'descriptionModule': {'briefSummary': 'A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed lung cancer, excluding small cell carcinoma\n* Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998\n* The primary tumor must be radiographically measurable.\n* Age \\> 18.\n* Karnofsky performance status \\> 70.\n* FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually \\> 800 ml\n* Labs: WBC \\> 3000; platelet count \\> 100,000; serum creatinine \\< 1.5 mg/dl or creatinine clearance \\>60 ml/min.\n* Laboratory values must be obtained \\< 3 weeks prior to registration.\n* A signed informed consent.\n* Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy.\n\nExclusion Criteria:\n\n* Patients with medical contraindication to chemotherapy or radiotherapy.\n* Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia.\n* Women who are pregnant.\n* Patients with small cell carcinoma or mesothelioma'}, 'identificationModule': {'nctId': 'NCT00178256', 'briefTitle': 'Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers', 'orgStudyIdInfo': {'id': 'URCC 1597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1st dose cohort 15mg/m2 taxol plus RT', 'description': '15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.\n\nOn Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible', 'interventionNames': ['Drug: Paclitaxel', 'Procedure: Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': '2nd dose cohort20 mg/m2 taxol plus daily RT', 'interventionNames': ['Drug: Paclitaxel', 'Procedure: Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': '3rd Dose Cohort --25mg/m2 taxol plus RT', 'interventionNames': ['Drug: Paclitaxel', 'Procedure: Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Arm --20mg/m2 taxol plus RT', 'interventionNames': ['Drug: Paclitaxel', 'Procedure: Radiation Therapy']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.', 'armGroupLabels': ['1st dose cohort 15mg/m2 taxol plus RT', '2nd dose cohort20 mg/m2 taxol plus daily RT', '3rd Dose Cohort --25mg/m2 taxol plus RT', 'Phase II Arm --20mg/m2 taxol plus RT']}, {'name': 'Radiation Therapy', 'type': 'PROCEDURE', 'description': 'Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible', 'armGroupLabels': ['1st dose cohort 15mg/m2 taxol plus RT', '2nd dose cohort20 mg/m2 taxol plus daily RT', '3rd Dose Cohort --25mg/m2 taxol plus RT', 'Phase II Arm --20mg/m2 taxol plus RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester, Dept. Radiation Oncology', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Yuhchyau Chen, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universtiy of Rochester, Dept of Radiation Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yuhchyau Chen', 'investigatorAffiliation': 'University of Rochester'}}}}