Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT04834206
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2021-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nedaplatin in Treatment for Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C053989', 'term': 'nedaplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-03', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective response rate (ORR)', 'timeFrame': 'at the end of radiotherapy(±1week）', 'description': 'CR+PR'}], 'secondaryOutcomes': [{'measure': 'Overall Survival(OS)', 'timeFrame': '3 years', 'description': 'The OS was defined as the duration from the date of beginning of treatment to the date of death from any cause or censored at the date of the last follow-up.'}, {'measure': 'Progress-Free Survival (PFS)', 'timeFrame': '3 years', 'description': 'Progress-free survival is calculated from the date of beginning of treatment to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.'}, {'measure': 'Locoregional Relapse-Free Survival(LRRFS)', 'timeFrame': '3 years', 'description': 'Relapse-free survival was defined as the time from beginning of treatment to local or regional relapse, or death from any cause.'}, {'measure': 'Distant metastasis-Free Survival(DMFS)', 'timeFrame': '3 years', 'description': 'Distant metastasis-free survival was defined as the time from beginning of treatment to distant metastasis, or death from any cause.'}, {'measure': 'Quality of life (QoL)', 'timeFrame': '3 years', 'description': 'Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H\\&N35). The EORTC QLQ-H\\&N35 scale employs a 4-point response format ("not at all" to "very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient\'s language habits.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Induction chemotherapy', 'Nedaplatin', 'Concurrent chemoradiotherapy', 'Nasopharyngeal Carcinoma'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.', 'detailedDescription': 'This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III\n* Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system\n* No evidence of distant metastasis (M0)\n* Age between 18-65\n* WBC≥4×10\\^9/ l, platelet ≥ 100×10\\^9/ l and hemoglobin ≥ 90g/l\n* With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)\n* With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)\n* Satisfactory performance status: KARNOFSKY scale (KPS) \\> 70\n* Patients must give signed informed consent\n\nExclusion Criteria:\n\n* Treatment with palliative intent\n* The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)\n* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer\n* History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes\n* History of previous radiotherapy\n* Pregnancy or lactation\n* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance.'}, 'identificationModule': {'nctId': 'NCT04834206', 'briefTitle': 'Nedaplatin in Treatment for Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}, 'officialTitle': 'Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.', 'orgStudyIdInfo': {'id': 'NPC-NDP-SGL arm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DNF-N', 'description': '1. Induction chemotherapy:\n\n three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks\n2. Concurrent chemoradiotherapy:\n\n three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy\n3. Radiotherapy: radical intense modulated radiation therapy', 'interventionNames': ['Drug: Docetaxel, nedaplatin, fluorouracil', 'Radiation: IMRT', 'Drug: Nedaplatin']}], 'interventions': [{'name': 'Docetaxel, nedaplatin, fluorouracil', 'type': 'DRUG', 'otherNames': ['DNF'], 'description': 'Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.', 'armGroupLabels': ['DNF-N']}, {'name': 'IMRT', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': 'Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.', 'armGroupLabels': ['DNF-N']}, {'name': 'Nedaplatin', 'type': 'DRUG', 'otherNames': ['N'], 'description': 'Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.', 'armGroupLabels': ['DNF-N']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jinquan Liu, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Section Chief', 'investigatorFullName': 'Jin-Quan Liu', 'investigatorAffiliation': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}}}}