Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
Study NCT ID:
NCT01537406
Status:
UNKNOWN
Last Update Posted:
2012-03-09
First Post:
2012-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 314}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.', 'timeFrame': '8 years post RT', 'description': "A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire"}], 'secondaryOutcomes': [{'measure': 'Does breast IMRT reduce the occurrence of late radiation therapy side effects', 'timeFrame': '8 years post RT', 'description': 'A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.\n\nBreast Cancer Treatment Outcome Scale (BCTOS) questionnaire'}, {'measure': 'Does breast IMRT effect long term QOL', 'timeFrame': '8 Years post RT', 'description': 'A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.\n\nBreast Cancer Treatment Outcome Scale (BCTOS) questionnaire'}, {'measure': 'Does IMRT effect local recurrence rates, overall and disease free survivals.', 'timeFrame': '8 years post RT', 'description': 'Data collection of local recurrences, overall and disease free survivals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.', 'detailedDescription': 'The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".\n\nThe investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer subjects treated in Toronto, Ontario, or in Victoria, British Columbia that participated in The Canadian breast IMRT clinical trial between July 2003 to March 2005.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study\n\nExclusion Criteria:\n\n* Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.'}, 'identificationModule': {'nctId': 'NCT01537406', 'acronym': 'BIMRT', 'briefTitle': 'Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy', 'orgStudyIdInfo': {'id': 'BCCABreastIMRT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY', 'type': 'RADIATION', 'description': 'LONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V8R6V5', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Vancouver Island Cancer Centre', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jean-Philippe Pignol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odette Cancer Centre'}, {'name': 'Pauline Truong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BCCA - Vancouver Island Cancer Centre'}, {'name': 'Ivo Olivotto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BCCA - Vancouver Island Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}