Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-02 @ 5:51 PM
Study NCT ID:
NCT02111460
Status:
UNKNOWN
Last Update Posted:
2020-05-08
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.'}], 'secondaryOutcomes': [{'measure': 'Progress-free survival', 'timeFrame': '2 years', 'description': 'Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.'}, {'measure': 'Complete Response (CR)', 'timeFrame': 'after the completion of the chemoradiotherapy treatment (up to 9 weeks)', 'description': 'CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Initially', 'Untreated', 'Distant metastatic'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32701129', 'type': 'DERIVED', 'citation': 'You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with initial untreated metastatic nasopharyngeal carcinoma\n* Histologic diagnosis of nasopharyngeal carcinoma\n* T1-4N0-3M1,IVC(according to the 7th AJCC edition)\n* Aged between 18 and 65 years\n* KPS≥70\n* The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu\n* Voluntary to participate and sign informed consent document\n\nExclusion Criteria:\n\n* The patients suffered from serious neurologic disease\n* Clinically significant cardiac, heart function less than or equal to 3 level\n* Clinically significant respiratory disease,lung function less than or equal to 3 level\n* Blood routine examination: WBC\\<3×109/L, Hemoglobin\\<90g/L, platelet count\\<75×109/L\n* Abnormal liver function: total bilirubin or ALT or AST\\>2×ULN\n* Abnormal renal function:serum creatinine\\>1.5×ULN\n* Pregnant or lactating women\n* The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu'}, 'identificationModule': {'nctId': 'NCT02111460', 'briefTitle': 'Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity', 'orgStudyIdInfo': {'id': 'SYSUCC5010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy', 'description': 'Systemic Chemotherapy Combined with Loco-regional Radiotherapy', 'interventionNames': ['Radiation: Loco-regional Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'Chemotherapy alone without Loco-regional Radiotherapy', 'interventionNames': ['Radiation: Loco-regional Radiotherapy']}], 'interventions': [{'name': 'Loco-regional Radiotherapy', 'type': 'RADIATION', 'description': 'with or without Loco-regional Radiotherapy', 'armGroupLabels': ['Chemotherapy', 'Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Ming y Chen, MD,Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor & chief physician', 'investigatorFullName': 'Ming-Yuan Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}