Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 9:39 PM
Study NCT ID:
NCT01717261
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2012-10-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ipsilateral breast cancer recurrence', 'timeFrame': '5 years'}], 'primaryOutcomes': [{'measure': 'Acute toxicity', 'timeFrame': '6 months', 'description': 'Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.'}], 'secondaryOutcomes': [{'measure': 'Chronic toxicity', 'timeFrame': '2 years', 'description': 'Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale'}, {'measure': 'Cosmetic outcome', 'timeFrame': '5 years', 'description': 'Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'early breast cancer', 'partial breast irradiation', 'preoperative radiation'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged 60 years or older.\n* Invasive ductal carcinoma.\n* Unifocal disease.\n* Tumors less than 2cm.\n* No clinical evidence of nodal disease.\n* Estrogen receptor status (ER) positive.\n* Her2 negative.\n\nExclusion Criteria:\n\n* Age less than 60 years.\n* BRCA 1 and/or BRCA 2 mutation.\n* Tumour histology limited to lobular carcinoma only.\n* Neoadjuvant hormonal manipulation or chemotherapy.\n* More than one primary tumour in different quadrants of the same breast.\n* Inability to view tumor on imaging.'}, 'identificationModule': {'nctId': 'NCT01717261', 'acronym': 'SPORT', 'briefTitle': 'Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'orgStudyIdInfo': {'id': '12030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Pre-Operative Radiation Therapy', 'interventionNames': ['Radiation: Single Pre-Operative Radiation Therapy']}], 'interventions': [{'name': 'Single Pre-Operative Radiation Therapy', 'type': 'RADIATION', 'description': 'Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.', 'armGroupLabels': ['Single Pre-Operative Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Michael Yassa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maisonneuve-Rosemon Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Michael Yassa', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}