Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-29 @ 11:12 PM
Study NCT ID:
NCT01854203
Status:
UNKNOWN
Last Update Posted:
2013-07-30
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for 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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-28', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rates of toxicity', 'timeFrame': '3-years', 'description': 'Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3-year', 'description': 'Overall survival is calculated from randomization to death from any cause.'}, {'measure': 'Failure-free survival', 'timeFrame': '3-year', 'description': 'Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.'}, {'measure': 'Locoregional failure-free survival', 'timeFrame': '3-year', 'description': 'the latency to the first local failure'}, {'measure': 'Distant failure-free survival', 'timeFrame': '3-year', 'description': 'The latency to the first remote failure'}], 'secondaryOutcomes': [{'measure': 'Difference in the complete response rates between the two treatment arms', 'timeFrame': '12 weeks after the completion of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cisplatin', 'neoadjuvant chemotherapy', 'intensity-modulated radiation therapy', 'concurrent chemoradiotherapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.', 'detailedDescription': 'The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.'}, '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 (according to World Health Organization (WHO 2005) histologically type).\n* A Karnofsky performance status of at least 80;\n* Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.\n* Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.\n* 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 ≤ULN.\n* Adequate renal function: a creatinine clearance rate of at least 60 mL/min.\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* WHO Type keratinizing squamous cell carcinoma.\n* Age \\>65 years or \\<18 years.\n* Distant metastasis,\n* Treatment with palliative intent.\n* Pregnancy or lactation.\n* a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.\n* history of renal disease, unstable cardiac disease requiring treatment.'}, 'identificationModule': {'nctId': 'NCT01854203', 'acronym': 'NPC', 'briefTitle': 'Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'ChiECRCT-2013003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IInductive chemotherapy + concurrent cisplatin and IMRT', 'description': 'Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.', 'interventionNames': ['Drug: Inductive chemotherapy + concurrent cisplatin and IMRT']}, {'type': 'EXPERIMENTAL', 'label': 'Inductive chemotherapy + IMRT', 'description': 'Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.', 'interventionNames': ['Drug: Inductive chemotherapy + IMRT']}], 'interventions': [{'name': 'Inductive chemotherapy + concurrent cisplatin and IMRT', 'type': 'DRUG', 'otherNames': ['Gemcitabine and cisplatin'], 'description': 'Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.', 'armGroupLabels': ['IInductive chemotherapy + concurrent cisplatin and IMRT']}, {'name': 'Inductive chemotherapy + IMRT', 'type': 'DRUG', 'otherNames': ['Gemcitabine and cisplatin'], 'description': 'Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.', 'armGroupLabels': ['Inductive chemotherapy + IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-jun Li, MD', 'role': 'CONTACT', 'email': 'lijj@sysucc.org.cn', 'phone': '+862087343381'}], 'facility': 'Cancer Center,Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-jun Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Li-zhi Liu, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Janjun Li, M.D.', 'role': 'CONTACT', 'email': 'lijj@sysucc.org.cn', 'phone': '+86+13829745245'}, {'name': 'Lizhi Liu, M.D.', 'role': 'CONTACT', 'email': 'liulizh@sysucc.org.cn', 'phone': '+86+13660528375'}], 'overallOfficials': [{'name': 'yong Su, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'Janjun Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'Lizhi Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jian-jun Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}