Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT01767935
Status:
TERMINATED
Last Update Posted:
2018-11-14
First Post:
2013-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dchilds@wakehealth.edu', 'phone': '336-716-2471', 'title': 'Dr. David Childs', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Medication Level, Assessed by Changes in Narcotic Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain After Cryosurgery, as Measured by the BPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], 'classes': [{'title': 'Least pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Average Pain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Right now', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Survived', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks post-cryosurgery', 'description': 'Count of participants that survived.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Cryosurgery and Radiation Therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncryosurgery: Undergo cryosurgery\n\nradiation therapy: Undergo radiation therapy\n\nquality-of-life assessment: Ancillary studies'}], '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': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', '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': '1', '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': '1', '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': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Slow Accruals', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2013-01-11', 'resultsFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2013-01-11', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-17', 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI', 'timeFrame': '24 hours', 'description': 'Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Pain Medication Level, Assessed by Changes in Narcotic Medication Usage', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.'}, {'measure': 'Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Pain After Cryosurgery, as Measured by the BPI', 'timeFrame': 'Up to 24 weeks', 'description': 'Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome'}, {'measure': 'Number of Participants Who Survived', 'timeFrame': 'Up to 24 weeks post-cryosurgery', 'description': 'Count of participants that survived.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bone Metastases', 'Pain']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Giving cryosurgery together with radiation therapy may kill more tumor cells', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the potential for efficacy and safety of combining percutaneous computed tomography (CT)-guided cryoablation and radiotherapy for the palliation of osseous metastases.\n\nOUTLINE:\n\nPatients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 24 hours and weeks 1-2, 4, 12, 18, and 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) confirmed metastatic disease with a new tumor involving or abutting bone that has the clinical and imaging features of metastatic disease\n\n * If the nature of the metastatic disease has been previously documented, index tumor to be treated does not require further documentation (i.e., biopsy)\n* Current analgesic therapies have failed (worst pain of 4 or above as measured by Brief Pain Inventory \\[BPI\\], despite analgesic therapy) OR the subject is experiencing intolerable side effects that preclude analgesic use (resulting in pain of 4 or above, as measured by BPI)\n* Pain must be from one or two painful metastatic sites in the bone (additional less painful metastatic sites may be present)\n\n * Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, magnetic resonance imaging (MRI), or ultrasound (US) imaging\n * Metastatic tumors must be amenable to cryoablation with CT or MRI\n* If the index tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots\n* Patients must have stable use of hormonal therapy for two weeks prior to study registration and two weeks prior to cryoablation procedure)\n* Stable use of pain medications (no changes within two weeks of cryoablation procedure)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Life expectancy \\>= 2 months\n* Platelets \\> 50,000/mm\\^3\n* International normalized ratio (INR) \\>= 1.5\n* Patients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up\n* Patients who are taking antiplatelet or anticoagulation medication (e.g., aspirin, ibuprofen, low molecular weight heparin \\[LMWH\\] preparations) must be able to discontinue such treatment prior to the cryoablation procedure for an appropriate amount of time; at least 5 days should be allowed after discontinuation of aspirin, Coumadin, clopidogrel, and dipyridamole; at least 12 hours should be allowed after discontinuation of LMWH preparations\n* Patients must be clinically suitable for cryoablation therapy\n* Patients must be clinically suitable for radiation therapy\n* Patients must be able to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with a diagnosis of leukemia, lymphoma, or myeloma\n* Patients with a tumor involving a weight-bearing long bone of the lower extremity with the tumor causing \\> 50% loss of cortical bone\n* Patients who have undergone prior ablation treatment or radiation therapy of the index tumor\n* Patients who have received chemotherapy within 14 days prior to and 14 days after cryoablation procedure\n* Index tumor(s) causing clinical or radiographic evidence of spinal cord or cauda equine compression/effacement\n* Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder\n* Any prior surgery at the proposed treatment site OR any prior surgery involving the cryoablation-treated tumor\n* Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)\n* Patients with uncontrolled coagulopathy or bleeding disorders\n* Patients who are pregnant, nursing, or who wish to become pregnant during the study\n* Patients with active, uncontrolled infection\n* Patients with serious medical illnesses, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within six months prior to study entry\n* Patients who are concurrently participating in any other experimental studies that could affect the primary endpoint of this study'}, 'identificationModule': {'nctId': 'NCT01767935', 'briefTitle': 'Cryosurgery and Radiation Therapy in Treating Patients With Painful Bone Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study of The Tandem Treatment of Painful Osseous Metastases With Cryoablation Followed by Radiation Therapy', 'orgStudyIdInfo': {'id': 'IRB00020528'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02087', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}, {'id': 'CCCWFU 97212', 'type': 'OTHER', 'domain': 'Wake Forest University Health Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (cryosurgery and radiation therapy)', 'description': 'Patients undergo cryosurgery. Beginning 2 weeks later, patients undergo 1, 10, or 15 fractions of radiation therapy 5 days per week for 1-3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Procedure: cryosurgery', 'Radiation: radiation therapy', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'cryosurgery', 'type': 'PROCEDURE', 'otherNames': ['cryoablation', 'cryosurgical ablation'], 'description': 'Undergo cryosurgery', 'armGroupLabels': ['Treatment (cryosurgery and radiation therapy)']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['irradiation', 'radiotherapy', 'therapy, radiation'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Treatment (cryosurgery and radiation therapy)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (cryosurgery and radiation therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David Childs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Endocare, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}