Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-12 @ 12:23 PM
Study NCT ID:
NCT04101760
Status:
UNKNOWN
Last Update Posted:
2019-10-08
First Post:
2019-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064146', 'term': 'Chemotherapy-Induced Febrile Neutropenia'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-05', 'studyFirstSubmitDate': '2019-09-21', 'studyFirstSubmitQcDate': '2019-09-21', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of febrile neutropenia', 'timeFrame': 'One year', 'description': 'Incidence of febrile neutropenia during each course of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of myelosuppression', 'timeFrame': 'One year', 'description': 'Incidence of febrile neutropenia during each course of chemotherapy'}, {'measure': 'Doses of granulocyte colony stimulating factor', 'timeFrame': 'One year', 'description': 'Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy'}, {'measure': 'Numbers of visits to the hospital', 'timeFrame': 'One year', 'description': 'Visits to the outpatient clinics and emergency room'}, {'measure': 'Adverse events', 'timeFrame': 'One years', 'description': 'Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03'}, {'measure': 'Progression-free survival', 'timeFrame': 'Two years', 'description': 'Progression-free survival after the treatment of ovarian cancer during the study periods'}, {'measure': 'Overall survival', 'timeFrame': 'Two years', 'description': 'Overall survival after the treatment of ovarian cancer during the study periods'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Neutropenia', 'Febrile Neutropenia, Drug-Induced', 'Epithelial Ovarian Cancer', 'Colony Stimulating Factors Adverse Reaction', 'Granulocyte Colony Stimulating Factor', 'Cost-effectiveness Analysis', 'Quality of Life', 'Progression-free Survival', 'Overall Survival']}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients.\n\nPatients receive platinum-based chemotherapy of 3 to 4 weeks. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines.\n\nThe primary end is the incidence of FN in every course of chemotherapy.\n\nThe secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF, quality of life, and survival outcomes (progression-free survival and overall survival).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With definitive pathological results of epithelial ovarian cancer\n* With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2\n* Aged 18 or older\n* Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery\n* Regularly followed up in the study centers\n* Provided consent for participation.\n\nExclusion Criteria:\n\n* Failure to meet all the inclusion criteria\n* Non-compliance with the study protocols\n* With a history of chemotherapy or pelvic radiotherapy for malignancies\n* Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome\n* Treated with weekly chemotherapy regimens\n* Presence of hematological disorders'}, 'identificationModule': {'nctId': 'NCT04101760', 'briefTitle': 'Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'EOC-CSF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor', 'interventionNames': ['Drug: Long-acting granulocyte colony stimulating factor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines', 'interventionNames': ['Drug: Short-acting granulocyte colony stimulating factor']}], 'interventions': [{'name': 'Long-acting granulocyte colony stimulating factor', 'type': 'DRUG', 'description': 'Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy', 'armGroupLabels': ['Study group']}, {'name': 'Short-acting granulocyte colony stimulating factor', 'type': 'DRUG', 'description': 'Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+8613911988831'}, {'name': 'Ming Wu, M.D.', 'role': 'CONTACT', 'email': 'wuming@pumch.cn', 'phone': '+8613801224549'}], 'overallOfficials': [{'name': 'Lei Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'The individual participant data will be shared as a supplement along with the published papers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Seventh Medical Center of PLA Army General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}