Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-28 @ 12:24 PM
Study NCT ID:
NCT04015661
Status:
UNKNOWN
Last Update Posted:
2019-07-11
First Post:
2019-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC
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': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D007267', 'term': 'Injections'}], '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': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '3 years', 'description': 'To be determined by measurement of target lesions according to RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival(PFS)', 'timeFrame': '3 years', 'description': 'From the date of enrollment to the date of either locally, regionally or distant failure or last follow-up'}, {'measure': 'Overall survival（OS）', 'timeFrame': '3 years', 'description': 'From the date of enrollment to the date of death is observed or to last follow-up visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age, 18-75 years old.\n2. Patients with newly histologically confirmed NPC.\n3. WHO Type Ⅱ and Ⅲ.\n4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).\n5. No serious organ dysfunction of heart, lung, liver, kidney.\n6. No distant metastasis.\n7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.\n8. Normal liver function test：Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \\<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5×ULN，creatinine clearance ≥60 ml/min.\n9. Patients must be given written informed consent.\n\nExclusion Criteria:\n\n1. age \\>75 years or \\<18years.\n2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.\n3. History of previous radiotherapy and chemotherapy.\n4. Known or suspected to be allergic to platinum and Nab-paclitaxel.\n5. Pregnancy or lactation.\n6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.\n7. Peripheral sensory neuropathy\\> grade 1.\n8. Uncontrolled heart clinical symptoms or diseases.'}, 'identificationModule': {'nctId': 'NCT04015661', 'briefTitle': 'Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC', 'organization': {'class': 'OTHER', 'fullName': 'Fuzhou General Hospital'}, 'officialTitle': 'Induction Chemotherapy With Nab-paclitaxel and Nedaplatin Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': '20190515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nab-paclitaxel+Nedaplatin', 'description': 'induction chemotherapy by nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy', 'interventionNames': ['Drug: Nab-paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel+Nedaplatin', 'description': 'induction chemotherapy by paclitaxel and nedaplatin followed by concurrent chemoradiotherapy', 'interventionNames': ['Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Paclitaxel for Injection (Albumin Bound)'], 'description': 'induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy', 'armGroupLabels': ['Nab-paclitaxel+Nedaplatin', 'Paclitaxel+Nedaplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wenmin ying, bachelor', 'role': 'CONTACT', 'phone': '15080015210'}], 'facility': 'No. 156, North Road, Xierhuan Road', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'wenmin ying, bachelor', 'role': 'CONTACT', 'email': '18352770@qq.com', 'phone': '228 59125'}, {'name': 'xiaoyan li', 'role': 'CONTACT', 'phone': '228 59125'}], 'overallOfficials': [{'name': 'zhichao fu, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuzhou General Hospital of Nanjing Military Regio，Department of Radiotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuzhou General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}