Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-26 @ 5:02 AM
Study NCT ID:
NCT01030757
Status:
TERMINATED
Last Update Posted:
2015-07-07
First Post:
2009-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bliem@salud.unm.edu', 'phone': '505-272-0086', 'title': 'Ben Liem, MD', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tomotherapy', 'description': 'Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.\n\nTomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days\n\n* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours\n* Dose will be prescribed to the isodose line which covers at least 90% of the PTV\n* Dose homogeneity +/- 5%', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tumor Response Rate (Complete Response + Partial Response).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomotherapy', 'description': 'Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.\n\nTomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days\n\n* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours\n* Dose will be prescribed to the isodose line which covers at least 90% of the PTV\n* Dose homogeneity +/- 5%'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to low accrual; no results to report'}, {'type': 'SECONDARY', 'title': 'Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomotherapy', 'description': 'Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.\n\nTomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days\n\n* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours\n* Dose will be prescribed to the isodose line which covers at least 90% of the PTV\n* Dose homogeneity +/- 5%'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to low accrual; no results to report.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tomotherapy', 'description': 'Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.\n\nTomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days\n\n* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours\n* Dose will be prescribed to the isodose line which covers at least 90% of the PTV\n* Dose homogeneity +/- 5%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '8 subjects were screened; 6 did not meet entry criteria. 2 subjects were enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tomotherapy', 'description': 'Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.\n\nTomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days\n\n* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours\n* Dose will be prescribed to the isodose line which covers at least 90% of the PTV\n* Dose homogeneity +/- 5%'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '68', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low accrual rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-13', 'studyFirstSubmitDate': '2009-12-09', 'resultsFirstSubmitDate': '2015-06-13', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-13', 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Response Rate (Complete Response + Partial Response).', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver Cancer', 'Metastatic Liver Cancer', 'Tomotherapy', 'Stereotactic Body Radiation Therapy'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cancer.unm.edu', 'label': 'University of New Mexico Cancer Center'}, {'url': 'http://www.nmcca.org', 'label': 'New Mexico Cancer Care Alliance'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.', 'detailedDescription': "The purpose of this study is to determine the response of liver tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety. The usual treatment for this type of disease for patients who are eligible is surgery to remove the tumors. For patients who aren't eligible for surgery or who chose not to have surgery, they are treated with low daily doses of radiation given over many weeks; however this type of treatment has not been very effective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic confirmation of solid primary tumor metastatic to liver\n* Age greater than or equal to 18 years old\n* Zubrod performance status less than or equal to 1\n* Negative pregnancy test for women of child bearing potential\n* Informed consent\n* Less than or equal to 3 liver metastases\n* Each lesion must be less than or equal to 6 cm in maximal diameter\n* No prior radiation to lesions being treated\n* Patient is not a surgical candidate or refuses surgery\n* Absolute neutrophil count ≥ 1800\n* Platelets ≥ 100000\n* Hemoglobin ≥8.0\n* Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT\n* At time of radiation treatment planning, at least 700 cc of normal liver must receive less than 15 Gy\n\nExclusion Criteria:\n\n* Contraindications to radiation\n* Pregnant or lactating females who chose to breast feed\n* Patients must have recovered from toxicity of prior therapy\n* Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications\n* Patients currently receiving anticoagulation with coumadin or IV heparin\n* Liver cirrhosis\n* Clinical ascites\n* Bilirubin \\> 3, Albumin \\< 2.5, liver enzymes 3 times above normal, Creatinine \\> 1.8"}, 'identificationModule': {'nctId': 'NCT01030757', 'briefTitle': 'Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico Cancer Research Alliance'}, 'officialTitle': 'Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver', 'orgStudyIdInfo': {'id': 'INST 0819'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02945', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tomotherapy', 'description': 'Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.', 'interventionNames': ['Radiation: Tomotherapy treatment']}], 'interventions': [{'name': 'Tomotherapy treatment', 'type': 'RADIATION', 'description': '* A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days\n* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours\n* Dose will be prescribed to the isodose line which covers at least 90% of the PTV\n* Dose homogeneity +/- 5%', 'armGroupLabels': ['Tomotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Ben Liem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}