Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
Study NCT ID:
NCT03196869
Status:
UNKNOWN
Last Update Posted:
2017-06-23
First Post:
2017-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2022-08-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2017-06-21', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '5 years', 'description': 'Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST'}], 'primaryOutcomes': [{'measure': 'Dendritic cell subgroup changes of Participants', 'timeFrame': 'termination of treatment, 3 months after treatment', 'description': 'By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with curative effect', 'timeFrame': '1 year', 'description': 'Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety', 'timeFrame': '5 year', 'description': 'To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NPC peripheral blood dendritic cell chronic-chemotherap'], 'conditions': ['Locally Advanced Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.', 'detailedDescription': "TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.\n2. KPS≥70 points.\n3. the age of 18-70 years old, male or female.\n4. no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).\n5. understand this study and signed informed consent\n\nExclusion Criteria:\n\n1. Three months in the use of Chinese herbal medicine or immune modulators\n2. distant metastasis.\n3. who had received prior chemotherapy.\n4. patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.\n5. pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.'}, 'identificationModule': {'nctId': 'NCT03196869', 'briefTitle': 'the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Guiyang Medical University'}, 'officialTitle': 'Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer', 'orgStudyIdInfo': {'id': '201708112121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chrono-chemotherapy group', 'description': 'Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group', 'interventionNames': ['Device: Chrono-chemotherapy', 'Drug: induction Chrono-chemotherapy', 'Drug: cisplatin chrono-chemotherapy', 'Radiation: intensity-modulated radiation therapy']}, {'type': 'OTHER', 'label': 'Routine intravenous drip', 'description': 'control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy', 'interventionNames': ['Device: Routine intravenous drip', 'Drug: induction Routine-chemotherapy', 'Drug: cisplatin routine-chemotherapy', 'Radiation: intensity-modulated radiation therapy']}], 'interventions': [{'name': 'Chrono-chemotherapy', 'type': 'DEVICE', 'otherNames': ['Experimental group'], 'description': 'Chrono-chemotherapy+concurrent radiochemotherapy', 'armGroupLabels': ['Chrono-chemotherapy group']}, {'name': 'Routine intravenous drip', 'type': 'DEVICE', 'otherNames': ['control group'], 'description': 'Routine intravenous drip-chemotherap', 'armGroupLabels': ['Routine intravenous drip']}, {'name': 'induction Chrono-chemotherapy', 'type': 'DRUG', 'otherNames': ['chronological dosage'], 'description': 'Experimental group:docetaxel,cisplatin,5-FU', 'armGroupLabels': ['Chrono-chemotherapy group']}, {'name': 'induction Routine-chemotherapy', 'type': 'DRUG', 'otherNames': ['Conventional drug delivery'], 'description': 'control group:docetaxel,cisplatin,5-FU', 'armGroupLabels': ['Routine intravenous drip']}, {'name': 'cisplatin chrono-chemotherapy', 'type': 'DRUG', 'otherNames': ['cisplatin Conventional drug delivery'], 'description': 'Experimental group: cisplatin chrono-chemotherapy', 'armGroupLabels': ['Chrono-chemotherapy group']}, {'name': 'cisplatin routine-chemotherapy', 'type': 'DRUG', 'otherNames': ['cisplatin Conventional drug delivery'], 'description': 'control group:cisplatin routine-chemotherapy', 'armGroupLabels': ['Routine intravenous drip']}, {'name': 'intensity-modulated radiation therapy', 'type': 'RADIATION', 'description': 'control group is similar to Experimental group', 'armGroupLabels': ['Chrono-chemotherapy group', 'Routine intravenous drip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '550000', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Jin, Bachelor', 'role': 'CONTACT', 'email': 'jinf8865@yahoo.com.cn', 'phone': '0851-86512802'}, {'name': 'Weili Wu, master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jinhua Long, master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuanyuan Li, master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiuyun Gong, Bachelor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiaoxiao Chen, Bachelor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juan Li, Bachelor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cancer Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}], 'centralContacts': [{'name': 'Feng Jin, Bachelor', 'role': 'CONTACT', 'email': 'jinf8865@yeah.net', 'phone': '0851-86512802'}, {'name': 'Juan Li, Bachelor', 'role': 'CONTACT', 'email': '1348330985@qq.com', 'phone': '0851-86512802'}], 'overallOfficials': [{'name': 'Feng Jin, Bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Guizhou Provincial Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guiyang Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head and neck cancer director, chief researcher, clinical professor', 'investigatorFullName': 'Feng Jing', 'investigatorAffiliation': 'Guiyang Medical University'}}}}