Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-01 @ 3:29 AM
Study NCT ID:
NCT04542356
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2020-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade 3-4 neutropenia', 'timeFrame': '2 months', 'description': 'Incidence of Grade 3-4 neutropenia'}, {'measure': 'Duration of grade 3-4 neutropenia', 'timeFrame': '2 months', 'description': 'Duration of grade 3-4 neutropenia'}], 'secondaryOutcomes': [{'measure': 'Incidence of febrile neutropenia (FN)', 'timeFrame': '2 months', 'description': 'Incidence of febrile neutropenia (FN)'}, {'measure': 'the rate of postponement of the course of radiotherapy', 'timeFrame': '2 months', 'description': 'the rate of postponement of the course of radiotherapy'}, {'measure': 'reduction in chemotherapy dose', 'timeFrame': '2 months', 'description': 'reduction in chemotherapy dose'}, {'measure': 'postponement of the course of chemotherapy', 'timeFrame': '2 months', 'description': 'postponement of the course of chemotherapy'}, {'measure': 'Changes of bone marrow function in patients 3 months and 6 months after radiotherapy', 'timeFrame': '6 months', 'description': 'Changes of bone marrow function in patients 3 months and 6 months after radiotherapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Cancer', 'concurrent chemoradiotherapy', 'neutropenia', 'PEG-rhG-CSF'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Cartmell MP, Ziegler SW, Neill DS. On the performance prediction and scale modelling of a motorised momentum exchange propulsion tether[J]. Gynecol Oncol, 2003, 654 (1): 571-579.'}, {'pmid': '25552400', 'type': 'BACKGROUND', 'citation': 'Liu Y, Zhang X, An S, Wu Y, Hu G, Wu Y. Pharmacokinetics of neamine in rats and anti-cervical cancer activity in vitro and in vivo. Cancer Chemother Pharmacol. 2015 Mar;75(3):465-74. doi: 10.1007/s00280-014-2658-7. Epub 2015 Jan 1.'}, {'pmid': '21133629', 'type': 'BACKGROUND', 'citation': 'Saha A, Chaudhury AN, Bhowmik P, Chatterjee R. Awareness of cervical cancer among female students of premier colleges in Kolkata, India. Asian Pac J Cancer Prev. 2010;11(4):1085-90.'}, {'type': 'BACKGROUND', 'citation': "Moore TD，Patel T，et al．A sir pesfligrastim dose per cycle supports dose-dense(q14d)CHOP-R in patients with non Hodgkin's lymphoma[J]．Proc Am Soc Hematol，2003，102(11): 2365．"}, {'pmid': '16305982', 'type': 'BACKGROUND', 'citation': 'Lokich J. Same-day pegfilgrastim and chemotherapy. Cancer Invest. 2005;23(7):573-6. doi: 10.1080/07357900500276899.'}, {'pmid': '34078317', 'type': 'DERIVED', 'citation': 'Zou D, Guo M, Zhou Q. A clinical study of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing neutropenia during concurrent chemoradiotherapy of cervical cancer. BMC Cancer. 2021 Jun 2;21(1):661. doi: 10.1186/s12885-021-08364-9.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.', 'detailedDescription': "Study design: In this prospective, single-center, randomized controlled study, patients with locally advanced cervical cancer are randomly divided into two groups. Patients in the experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC returned to 2✕109/L.\n\nCase selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent Radiotherapy.\n\nPrimary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after radiotherapy.\n\nSafety assessment: laboratory safety testing, including platelet count and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, bone pain, etc."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years old;\n* Patients with cervical cancer who have not undergone surgery for initial treatment, the international union of gynecology and obstetrics (FIGO) stage IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology.\n* The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;\n* Bone marrow hematopoietic function is normal before treatment (ANC≥1.8×109/L, PLT≥100×109/L, Hb≥90g/L, WBC≥4.0×109/L);\n* No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction;\n* All patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment, and women of childbearing age must have a negative urine pregnancy test prior to treatment administration;\n* The subjects voluntarily participate in this clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\n* Those who refuse to accept PEG-rh-G-CSF;\n* Currently conducting clinical trials of other drugs;\n* Uncontrolled infection before treatment, body temperature ≥ 38℃;\n* Chronic diseases of the heart, kidney, liver or other important organs;\n* Patients with severe uncontrolled diabetes;\n* Pregnant or lactating female patients;\n* Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli;\n* Suspected or confirmed drug, substance or alcohol abuse;\n* Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation;\n* HIV-positive people;\n* Patients requiring radiation therapy for the retroperitoneal or inguinal region.'}, 'identificationModule': {'nctId': 'NCT04542356', 'briefTitle': 'Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing University Cancer Hospital'}, 'officialTitle': 'Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer', 'orgStudyIdInfo': {'id': 'CQGOG0104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy', 'interventionNames': ['Drug: PEG-rhG-CSF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'patients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC\\<1✕109/L', 'interventionNames': ['Drug: rhG-CSF']}], 'interventions': [{'name': 'PEG-rhG-CSF', 'type': 'DRUG', 'description': "During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.", 'armGroupLabels': ['experimental group']}, {'name': 'rhG-CSF', 'type': 'DRUG', 'description': "Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.", 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Dongling Zou, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chongqing University Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Director', 'investigatorFullName': 'Dongling Zou', 'investigatorAffiliation': 'Chongqing University Cancer Hospital'}}}}