Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-06 @ 12:36 AM
Study NCT ID:
NCT02067858
Status:
TERMINATED
Last Update Posted:
2018-07-18
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System
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': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'holevakd@upmc.edu', 'phone': '412-623-1275', 'title': 'Karen Holeva', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent\n\nStereotactic Radiosurgery', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent\n\nStereotactic Radiosurgery'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'The Number of Patients that completed SBRT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent\n\nStereotactic Radiosurgery'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of patients with Progression Free Survival at 2 Years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation of Imaging Response With Serum Protein and Peptide Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent\n\nStereotactic Radiosurgery'}], 'timeFrame': '2 years', 'description': 'Research blood draws looking at imaging repsonse before and after radiation in relationship to serum protein and peptide profiles', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood draw samples were not drawn nor analyzed for this study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent\n\nStereotactic Radiosurgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent\n\nStereotactic Radiosurgery'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2014-02-14', 'resultsFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-20', 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation of Imaging Response With Serum Protein and Peptide Profiles', 'timeFrame': '2 years', 'description': 'Research blood draws looking at imaging repsonse before and after radiation in relationship to serum protein and peptide profiles'}], 'primaryOutcomes': [{'measure': 'Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC', 'timeFrame': '2 years', 'description': 'The Number of Patients that completed SBRT'}], 'secondaryOutcomes': [{'measure': 'Assess Progression-free Survival', 'timeFrame': '2 years', 'description': 'Number of patients with Progression Free Survival at 2 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer', '4D CT']}, 'descriptionModule': {'briefSummary': "The goals of this clinical research are to evaluate the outcomes and tumor response for early stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation Therapy (SBRT) using four dimensional (4D) Positron Emission Tomography (PET) and Computed Tomography (CT), Cone-Beam Computed Tomography (CBCT), Real-Time Position Management (RPM™) and body immobilization system (see figure 1). Specifically, the effect of image-guided SBRT treatment on clinical tumor response rate, local control and progression-free survival will be studied. This study will examine target volumes and relevant margins determined by an assessment using 4D PET and repeated 4D CT. These data will allow us to evaluate and determine the impact of the body immobilization system on the planning target volume (PTV) margins, patient's breathing pattern, target motion, and inter-treatment targets shifts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "The patient must be over the age of 18 years. Histologic confirmation of primary NSCLC of the lung tumor must be complete prior to SBRT treatment.\n\nThe following stages of NSCLC patients would be eligible for the study:\n\nStage I:\n\nT1 N0 M0 T2 N0 M0 (Size ≤ 5 cm)\n\nStage II:\n\nT3 N0 M0 (Chest wall invasion only, Size ≤ 5 cm)\n\nStaging Tumor size and characteristics: they will be determined by PET-CT scan\n\nNodal disease:\n\nPatients with chest CT scan demonstrating hilar or mediastinal nodes \\<1cm and/or PET negative would be considered N0 disease.\n\nPatients who have hilar or mediastinal nodes \\> 1 cm and PET scan negative may be considered N0 disease.\n\nIf PET scan demonstrates suspicious uptake or abnormal uptake, these patients would be eligible, if a directed biopsy (by mediastinoscopy, Chamberlein procedure or other modalities such as trans-bronchial biopsy, CT guided biopsy) is negative.\n\nMetastases:\n\nEvaluated by PET-CT scanning and biopsy as indicated\n\nThe patient must have an ECOG/Zubrod performance status of 0, 1, or 2. In order to be considered medically-inoperable, the patient must meet at least one major criterion or meet a minimum of 2 minor criteria as described below.\n\nMAJOR CRITERIA:\n\nFEV1 \\< 50% or predicted postoperative FEV1 \\< 40% DLCO \\< 50% or predicted postoperative DLCO \\< 40% Exercise induced maximal exercise oxygen consumption (MVO2)\\<15 ml/kg/min Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine if the patient is medically operable This criterion would be mandatory\n\nMINOR CRITERIA:\n\nAge \\> 80 Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) Oxygen requirement (using the Medicare criteria for home oxygen requirements \\[i.e., room air oxygen saturation of 88% or less\\]) Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion) Poor left ventricular function (defined as an ejection fraction of 40% or less) Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease Diabetes Mellitus with severe organ damage such as End-Stage Renal Disease (ESRD), Blindness, Vascular disease.\n\nCBC, Diff and platelets, Comprehensive metabolic panel within 28 days of registration meeting the following criteria\n\nleukocytes \\>3,000/mcL absolute neutrophil count \\>1,500/mcL hemoglobin \\>9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors) platelets \\>100,000/mcL total bilirubin \\<1.5x institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance \\>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n\nFemales of child-bearing age must be using a reliable form of birth control. The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures.\n\nThe patient must provide written authorization to allow for the use and disclosure of their protected Health information.\n\nConditions for Patient Ineligibility The patient's weight exceeds the tolerances of the institution's imaging and treatment platform/couch.\n\nThe patient has received thoracic radiation therapy in the same region as the current SBRT planned treatment area. The patient has completed chemotherapy within 30 days of treatment. T2: Tumor size \\> 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described criteria would also be excluded.\n\nPancoast tumors would be excluded. Current distant metastatic disease (M1) (preferably biopsy proven). The patient is a female with child-bearing potential who refuses to obtain a serum pregnancy test prior to the initiation of treatment.\n\nThe patient is pregnant or a female who is nursing an infant. The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation The patient has an active systemic or pulmonary infection."}, 'identificationModule': {'nctId': 'NCT02067858', 'briefTitle': 'An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System', 'orgStudyIdInfo': {'id': '10-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stereotactic Radiosurgery', 'description': '3 fractions x 20 Gy 4 fractions x 12 Gy\n\nLesion dependent', 'interventionNames': ['Radiation: Stereotactic Radiosurgery']}], 'interventions': [{'name': 'Stereotactic Radiosurgery', 'type': 'RADIATION', 'otherNames': ['SBRT', 'SRS', 'Trilogy', 'True Beam', 'Cyber Knife'], 'armGroupLabels': ['Stereotactic Radiosurgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Shadyside Radiation Oncology Department', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Dwight E Heron, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steven Burton', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Steven Burton', 'investigatorAffiliation': 'University of Pittsburgh'}}}}