Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT00003404
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003557', 'term': 'Phyllodes Tumor'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Richard.J.Barth.Jr@hitchcock.org', 'phone': '(603) 650-9479', 'title': 'Richard J. Barth Jr., MD', 'organization': 'Dartmouth Hitchcock Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adjuvant Radiotherapy', 'description': 'Adjuvant radiation after local excision or breast re-excision.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local Recurrence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjuvant Radiotherapy', 'description': 'Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.\n\nAdjuvant Radiotherapy: Adjuvant radiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'rate of occurance', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0', 'ciUpperLimit': '8', 'estimateComment': 'The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months after initial excision', 'description': 'Local recurrence rate of phyllodes tumors', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjuvant Radiotherapy', 'description': 'Adjuvant radiation after local excision or breast re-excision.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 5 years', 'description': 'Survival will be tracked for 10 years after initial resection of first participant treated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adjuvant Radiotherapy', 'description': 'Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled from a total of 30 different institutions. Half of the patients were treated at community-based treatment centers, and half were treated at academic medical centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adjuvant Radiotherapy', 'description': 'Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', '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': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2008-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-30', 'studyFirstSubmitDate': '1999-11-01', 'resultsFirstSubmitDate': '2018-10-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-30', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Recurrence Rate', 'timeFrame': '36 months after initial excision', 'description': 'Local recurrence rate of phyllodes tumors'}], 'secondaryOutcomes': [{'measure': 'Survival Rate', 'timeFrame': 'Approximately 5 years', 'description': 'Survival will be tracked for 10 years after initial resection of first participant treated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'phyllodes tumor'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19424757', 'type': 'RESULT', 'citation': 'Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8.'}]}, 'descriptionModule': {'briefSummary': 'PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.\n* Determine the survival rate in patients treated with this regimen.\n\nMETHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n1. Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:\n\n 1. Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia\n 2. Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia\n2. Must have been excised with breast-conserving resection and no positive margins\n3. Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision\n4. No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast\n5. Hormone receptor status: Not specified\n\nPATIENT CHARACTERISTICS:\n\n1. Age: 18 and over\n2. Sex: Female\n3. Menopausal status: Not specified\n4. Performance status: Not specified\n5. Life expectancy: Not specified\n6. Hematopoietic: Not specified\n7. Hepatic: Not specified\n8. Renal: Not specified\n9. Other:\n\n 1. Not pregnant\n 2. Negative pregnancy test\n 3. Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n1. Biologic therapy: Not specified\n2. Chemotherapy: Not specified\n3. Endocrine therapy: Not specified\n4. Radiotherapy: No prior radiotherapy to the ipsilateral breast\n5. Surgery: See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003404', 'briefTitle': 'Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors', 'orgStudyIdInfo': {'id': 'D9801 CDR0000066410'}, 'secondaryIdInfos': [{'id': 'P30CA023108', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023108', 'type': 'NIH'}, {'id': 'DMS-9801'}, {'id': 'DMS-12752'}, {'id': 'NCI-V98-1442'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant Radiotherapy', 'description': 'Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.', 'interventionNames': ['Radiation: Adjuvant Radiotherapy']}], 'interventions': [{'name': 'Adjuvant Radiotherapy', 'type': 'RADIATION', 'description': 'Adjuvant radiation therapy', 'armGroupLabels': ['Adjuvant Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Richard J. Barth, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Norris Cotton Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Section of General Surgery', 'investigatorFullName': 'Richard J. Barth,Jr.', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}