Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01658956
Status:
UNKNOWN
Last Update Posted:
2015-01-06
First Post:
2012-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-05', 'studyFirstSubmitDate': '2012-07-27', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)', 'timeFrame': 'At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization'}], 'secondaryOutcomes': [{'measure': 'Need for unplanned hospitalization', 'timeFrame': 'At the beginning of second chemotherapy cycle, no more than 30 days after randomization', 'description': 'Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration'}, {'measure': 'Complicated febrile neutropenic episode', 'timeFrame': 'At the beginning of the second chemotherapy cycle, no more than 30 days after randomization', 'description': 'A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051'}, {'measure': 'Mortality any cause', 'timeFrame': '30 days from randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GCSF', 'Chemotherapy', 'Breast cancer', 'Prophylaxis'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBreast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant\n\nExclusion Criteria:\n\nEligibility to receive reimbursed GCSF'}, 'identificationModule': {'nctId': 'NCT01658956', 'acronym': 'PAPALDO', 'briefTitle': 'Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': "A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia", 'orgStudyIdInfo': {'id': 'Institut Jules Bordet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subcutaneous GCSF 5 µg/kg days 8 and 12', 'description': 'Prophylactic administration of GCSF on days 8 and 12 following chemotherapy', 'interventionNames': ['Drug: GCSF administration on days 8 and 12 after chemotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention'}], 'interventions': [{'name': 'GCSF administration on days 8 and 12 after chemotherapy', 'type': 'DRUG', 'armGroupLabels': ['Subcutaneous GCSF 5 µg/kg days 8 and 12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Aspasia Georgala, MD', 'role': 'CONTACT', 'email': 'aspasia.georgala@bordet.be', 'phone': '3225413255'}, {'name': 'Marianne Paesmans', 'role': 'CONTACT', 'email': 'marianne.paesmans@bordet.be', 'phone': '3225413399'}, {'name': 'Aspasia Georgala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}