Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT01175694
Status:
UNKNOWN
Last Update Posted:
2010-08-20
First Post:
2010-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2010-08-04', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local control rates', 'timeFrame': 'five years'}], 'secondaryOutcomes': [{'measure': 'late side effects', 'timeFrame': '5 years', 'description': 'to assess the incidence and severity of acute and late side effects of brachytherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brachytherapy', 'APBI', 'dose modification', 'local recurrences', 'side effects', 'cosmetic result'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.', 'detailedDescription': 'Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Stage 0, I or II breast cancer.\n* Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.\n* Ductal carcinoma in situ (DCIS) alone.\n* No lymph invasion (L0) and no hemangiosis (V0).\n* Lesions of \\< 3 cm diameter, histopathologically assured.\n* pN0 (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable).\n* M0.\n* Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.\n* For DCIS only: lesions must be classified as low or intermediate risk group\n* Unifocal and unicentric DCIS or breast cancer.\n* Age \\> 50 years.\n* Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.\n* Signed study-specific consent form\n\nExclusion Criteria:\n\n* Stage III or IV breast cancer.\n* Surgical margins that cannot be microscopically assessed.\n* Extensive intraductal component (EIC).\n* Paget's disease or pathological skin involvement.\n* Synchronous or previous breast cancer.\n* Prior malignancy (\\< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) 0 and I if patient is continuously disease-free.\n* Pregnant or lactating women.\n* Collagen vascular disease.\n* The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatic or similar.\n* Psychiatric disorders.\n* Patient with breast deemed technically unsatisfactory for brachytherapy."}, 'identificationModule': {'nctId': 'NCT01175694', 'briefTitle': 'Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Erlangen'}, 'officialTitle': 'Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer', 'orgStudyIdInfo': {'id': 'Brachy-APBI-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brachytherapy', 'description': 'Interstitial multicatheter brachytherapy', 'interventionNames': ['Radiation: Interstitial multicatheter brachytherapy']}], 'interventions': [{'name': 'Interstitial multicatheter brachytherapy', 'type': 'RADIATION', 'otherNames': ['APBI'], 'description': 'Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq', 'armGroupLabels': ['Brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Vratislav Strnad, MD, Prof.', 'role': 'CONTACT', 'email': 'vratislav.strnad@uk-erlangen.de', 'phone': '49 9131 8544205'}, {'name': 'Godehard Lahmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Radiation Oncology, University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Vratislav Strnad, MD, Prof.', 'role': 'CONTACT', 'email': 'vratislav.strnad@uk-erlangen.de', 'phone': '49 9131 8544205'}], 'overallOfficials': [{'name': 'Vratislav Strnad, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Erlangen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Vratislav Strnad, MD, Prof.', 'oldOrganization': 'University Hospital Erlangen'}}}}