Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-22 @ 6:37 AM
Study NCT ID:
NCT01571518
Status:
UNKNOWN
Last Update Posted:
2012-04-05
First Post:
2012-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-03', 'studyFirstSubmitDate': '2012-03-29', 'studyFirstSubmitQcDate': '2012-04-03', 'lastUpdatePostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of neutropenia', 'timeFrame': 'Change from Baseline in neutrophil count at 21days', 'description': 'during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['G-CSF', 'neutropenia', 'TAC'], 'conditions': ['Neutropenia']}, 'referencesModule': {'references': [{'pmid': '20232087', 'type': 'RESULT', 'citation': 'Chan A, Fu WH, Shih V, Coyuco JC, Tan SH, Ng R. Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy. Support Care Cancer. 2011 Apr;19(4):497-504. doi: 10.1007/s00520-010-0843-8. Epub 2010 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.', 'detailedDescription': 'The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy\n\nExclusion Criteria:\n\n* pregnancy,\n* cardiovascualr disease,\n* abnormal renal function,\n* hematologic disorder'}, 'identificationModule': {'nctId': 'NCT01571518', 'briefTitle': 'Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Sunchonhang University'}, 'officialTitle': 'Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase', 'orgStudyIdInfo': {'id': '2011-91'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early injection', 'description': 'injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy', 'interventionNames': ['Drug: late leukostim']}, {'type': 'SHAM_COMPARATOR', 'label': 'late injection', 'description': 'injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy', 'interventionNames': ['Drug: early leukostim']}], 'interventions': [{'name': 'late leukostim', 'type': 'DRUG', 'otherNames': ['5leuko'], 'description': 'injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy', 'armGroupLabels': ['early injection']}, {'name': 'early leukostim', 'type': 'DRUG', 'otherNames': ['2leuko'], 'description': 'injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy', 'armGroupLabels': ['late injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Puchun', 'country': 'South Korea', 'contacts': [{'name': 'Hyuk moon Kim, MD', 'role': 'CONTACT', 'email': 'hmkim@soonchunhyang.com', 'phone': '82-32-621-5114'}, {'name': 'ChulWan Lim, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soonchunhyang university Puchun Hospital'}], 'centralContacts': [{'name': 'Chul Wan Lim, M.D., Ph.D', 'role': 'CONTACT', 'email': 'cylim@soonchunhyang.com', 'phone': '82-32-621-5114'}], 'overallOfficials': [{'name': 'Chul Wan Lim, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Soonchunhyang U Puchun Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyuk moon Kim', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dong-A Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hyuk moon Kim', 'investigatorAffiliation': 'Sunchonhang University'}}}}