Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT04158518
Status:
UNKNOWN
Last Update Posted:
2019-11-08
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
De-escalation Protocols in Locoregionally Advanced 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-07', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS', 'timeFrame': '3 year', 'description': 'Disease Free Survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '3 year', 'description': 'Overall Survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'De-escalation'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of nasopharyngeal carcinoma\n* Stage III or IVA according to UICC/AJCC 8th staging system\n* Age ≥18\n* No prior anti-tumor treatment\n* Karnofsky Performance Score (KPS)≥70\n* Adequate blood supply\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Can not take contrast-MRI imaging\n* Pregnant\n* Combined with other malignant tumor (except basal cell carcinoma of skin)'}, 'identificationModule': {'nctId': 'NCT04158518', 'briefTitle': 'De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': '2019-NPC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toxicities reduced treatment', 'description': 'Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).', 'interventionNames': ['Radiation: Toxicities reduced treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).', 'interventionNames': ['Radiation: Conventional treatment']}], 'interventions': [{'name': 'Toxicities reduced treatment', 'type': 'RADIATION', 'description': 'Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.\n\nOmitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).\n\nRadiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.', 'armGroupLabels': ['Toxicities reduced treatment']}, {'name': 'Conventional treatment', 'type': 'RADIATION', 'description': 'Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.\n\nConcurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR).\n\nRadiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Youqi Yang, MD', 'role': 'CONTACT', 'email': 'yangyq@sina.com', 'phone': '+8613916162859'}, {'name': 'Xueguan Lu, MD', 'role': 'CONTACT', 'email': 'luxueguan@163.com', 'phone': '+8618121299382'}], 'facility': 'Fudan Universtiy Shanghai Cancer Centre', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Youqi Yang, MD', 'role': 'CONTACT', 'email': 'yangyq@sina.com', 'phone': '+8613916162859'}, {'name': 'Xueguan Lu, MD', 'role': 'CONTACT', 'email': 'luxueguan@163.com', 'phone': '+8618121299382'}], 'overallOfficials': [{'name': 'Chaosu Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University Shanghai Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chaosu Hu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chaosu Hu', 'investigatorAffiliation': 'Fudan University'}}}}