Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT02958033
Status:
UNKNOWN
Last Update Posted:
2016-11-08
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shandong Cancer Hospital Affiliated to Shandong University
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-04', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of acute skin toxicity', 'timeFrame': '2 Weeks after the end of radiotherapy.', 'description': 'To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost'}], 'secondaryOutcomes': [{'measure': 'local control', 'timeFrame': 'From data of randomization until 60 months after the end of radiotherapy of last patients', 'description': 'To determine the local control in women with early stage breast cancer treated with accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost'}, {'measure': 'Degree of chronic skin toxicity and cosmesis after radiotherapy', 'timeFrame': '6 months after radiotherapy', 'description': 'To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.'}, {'measure': 'Degree of chronic skin toxicity and cosmesis after radiotherapy', 'timeFrame': '2 years after radiotherapy', 'description': 'To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.'}, {'measure': 'Degree of chronic skin toxicity and cosmesis after radiotherapy', 'timeFrame': '5 years after radiotherapy', 'description': 'To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.'}, {'measure': 'overall survival', 'timeFrame': 'From date of randomization until 60 months after the end of radiotherapy of last patients', 'description': 'To determine whether the overall survival after hypo-fractionated breast radiation with concurrent boost is non-inferior to conventional fractionated radiation therapy with concurrent boost.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Early-stage Breast Cancer', 'Breast Conserving Surgery']}, 'descriptionModule': {'briefSummary': 'In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients has had breast conserving surgery\n2. age ≥ 18 and ≤ 65 years\n3. with a histological diagnosis of invasive carcinoma of the breast\n4. with pathological stage of T1-2N0-1M0\n5. multidisciplinary decision of adjuvant WBI with a boost to the tumor bed\n6. informed consent obtained, signed and dated before specific protocol procedures\n\nExclusion Criteria:\n\n1. patients treated with Mastectomy\n2. Need for lymph node irradiation\n3. positive or close(≤ 1 mm) surgical margin\n4. treated with neoadjuvant chemotherapy before surgery\n5. Bilateral malignancy of the breast (synchronous or metachronous)\n6. Pregnant or breastfeeding\n7. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study\n8. Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study'}, 'identificationModule': {'nctId': 'NCT02958033', 'briefTitle': 'Shandong Cancer Hospital Affiliated to Shandong University', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'Shandong Cancer Hospital Affiliated to Shandong University', 'orgStudyIdInfo': {'id': 'Shandong Cancer Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HF WBI-SIB breast radiation', 'description': 'WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18)', 'interventionNames': ['Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CF WBI-SIB breast radiation', 'description': 'WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28)', 'interventionNames': ['Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost']}], 'interventions': [{'name': 'Whole Breast irradiation Plus simultaneous tumor bed Boost', 'type': 'RADIATION', 'description': 'hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group', 'armGroupLabels': ['CF WBI-SIB breast radiation', 'HF WBI-SIB breast radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Xu', 'role': 'CONTACT', 'email': 'xumin7799@sina.com', 'phone': '+86-531-67626132'}], 'facility': 'Jiyan Road No.440', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Min Xu', 'role': 'CONTACT', 'email': 'xumin7799@sina.com', 'phone': '+86-531-67626132'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Min Xu', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}