Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 6:42 AM
Study NCT ID:
NCT01079832
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar 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': 'kunosc@summahealth.org', 'phone': '330-375-4485', 'title': 'Dr. Charles Kunos', 'organization': 'Case Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected while patients were receiving treatment and during 6 months of follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.', 'otherNumAtRisk': 50, 'otherNumAffected': 34, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': '"Fatigue (asthenia, lethargy, malaise)"', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Chest wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Death not associated with CTCAE term - Disease progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'notes': 'Additional adverse events associated with this hospitalization were:\n\nGrade 1 INR (International Normalized Ratio of prothrombin time) Grade 2 Liver dysfunction/failure (clinical)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'notes': 'Confusion - Brain metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Toxicity Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 6 months after treatment', 'description': 'The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '11.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'completion of study at 24 months', 'description': 'Median disease free survival', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Median Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '29.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'Length of time patients survived at study end.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'timeFrame': 'After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant surveys were unreliably returned to investigators, making this analysis not meaningful.'}, {'type': 'SECONDARY', 'title': 'Clinical Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '80'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 6 months from study entry', 'description': 'Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', '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': '48', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '45', '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': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2010-03-02', 'resultsFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-27', 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Toxicity Rate', 'timeFrame': 'at 6 months after treatment', 'description': 'The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival', 'timeFrame': 'completion of study at 24 months', 'description': 'Median disease free survival'}, {'measure': 'Median Overall Survival', 'timeFrame': '24 months', 'description': 'Length of time patients survived at study end.'}, {'measure': 'Quality of Life', 'timeFrame': 'After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.'}, {'measure': 'Clinical Response Rate', 'timeFrame': 'at 6 months from study entry', 'description': 'Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fallopian Tube Cancer', 'Ovarian Sarcoma', 'Ovarian Stromal Cancer', 'Recurrent Cervical Cancer', 'Recurrent Endometrial Carcinoma', 'Recurrent Ovarian Epithelial Cancer', 'Recurrent Ovarian Germ Cell Tumor', 'Recurrent Uterine Sarcoma', 'Recurrent Vaginal Cancer', 'Recurrent Vulvar Cancer', 'Stage III Cervical Cancer', 'Stage III Endometrial Carcinoma', 'Stage III Ovarian Epithelial Cancer', 'Stage III Ovarian Germ Cell Tumor', 'Stage III Uterine Sarcoma', 'Stage III Vaginal Cancer', 'Stage III Vulvar Cancer', 'Stage IV Endometrial Carcinoma', 'Stage IV Ovarian Epithelial Cancer', 'Stage IV Ovarian Germ Cell Tumor', 'Stage IV Uterine Sarcoma', 'Stage IV Vulvar Cancer', 'Stage IVA Cervical Cancer', 'Stage IVA Vaginal Cancer', 'Stage IVB Cervical Cancer', 'Stage IVB Vaginal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.\n\nPURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers.\n\nII. To evaluate clinical response to radio-surgery for gynecologic tumors.\n\nIII. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain.\n\nSECONDARY OBJECTIVES:\n\nI. As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery will also be described.\n\nOUTLINE:\n\nPatients undergo 3 fractions of CyberKnife stereotactic radiosurgery.\n\nAfter completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion\n\n* Pathologically proven gynecologic malignancy\n* No prior cryosurgery or radiofrequency ablation, in target lesion\n* Patient is able to give and sign study specific informed consent\n* Measurable disease, according to RECIST criteria\n* Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine\n* \\>= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy\n* ECOG performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients\n\nExclusion\n\n* Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded\n* Any patient with active Crohn's disease or active ulcerative colitis is excluded\n* Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded"}, 'identificationModule': {'nctId': 'NCT01079832', 'briefTitle': 'Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies', 'orgStudyIdInfo': {'id': 'CASE13808'}, 'secondaryIdInfos': [{'id': 'NCI-2010-00285', 'type': 'OTHER', 'domain': 'NCI/CTRP'}, {'id': 'CASE13808', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I: CyberKnife Radiosurgery', 'description': 'Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.', 'interventionNames': ['Radiation: stereotactic radiosurgery', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'stereotactic radiosurgery', 'type': 'RADIATION', 'description': 'Radiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist', 'armGroupLabels': ['Arm I: CyberKnife Radiosurgery']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I: CyberKnife Radiosurgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Robert DeBernardo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}