Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 5:04 PM
Study NCT ID:
NCT01596868
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate (ORR)', 'timeFrame': '3-year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3-year', 'description': 'Overall survival is calculated from randomization to death from any cause.'}, {'measure': 'Locoregional failure-free survival', 'timeFrame': '3-year', 'description': 'the date of randomization to the first local failure'}, {'measure': 'Distant failure-free survival', 'timeFrame': '3-year', 'description': 'from randomization to the first remote failure'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '3-year'}, {'measure': 'Quality of life', 'timeFrame': '3-year'}, {'measure': 'Acute adverse reaction', 'timeFrame': '3-year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced Nasopharyngeal Carcinoma', 'treatment', 'Northwest China'], 'conditions': ['Nasopharyngeal Squamous Cell Carcinoma', 'Toxicity Due to Radiotherapy']}, 'descriptionModule': {'briefSummary': 'The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC). The effectiveness, side effects and quality of life will be evaluated according to Standard WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H\\&N35 questionnaire.', 'detailedDescription': 'Nasopharyngeal carcinoma has an unique geographic distribution, and has different pathological types, natural history, treatment modalities in endemic and non-endemic regions. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. Chemoradiotherapy is the main therapy choice for the locoregionally advanced nasopharyngeal carcinoma. However,the optimal chemoradiotherapy regimen has not been determined. Many new drugs including docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The investigators designed the present study with induction chemotherapy follow by CCRT for locoregionally advanced NPC in non-endemic Northwest China, comparing induction chemotherapy regime of TP and GP. The primary objectives were overall response rate (ORR), acute toxicity, tolerance; second objective were overall survival (OS), progression free survival (PFS), rate of distant metastases,late adverse events and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven WHO II\\~III native NPC in northwest region of China;\n* 18 Years to 70 Years;\n* stages III-IVb according to AJCC stage classification(7th edition), no previous chemotherapy and radiotherapy;\n* Performance status: 0-1(ECOG);\n* WBC \\> 4.0X109/L, PLT \\> 100X109/L, with normal hepatic function(AST, ALT \\< 2.5 x upper limit of normal, and bilirubin \\< 1.5 x upper limit of normal), with normal renal function (Creatinine \\< 1.5 x upper limit of normal);\n* Ability to comply with trial requirements.\n\nExclusion Criteria:\n\n* Evidence of metastases by clinical or radiographic examinations;\n* History of malignancy;\n* Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.;\n* Patients with uncontrolled intercurrent disease;\n* Patients with currently active malignancy;\n* Pregnant or lactating women patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.'}, 'identificationModule': {'nctId': 'NCT01596868', 'briefTitle': 'GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China', 'orgStudyIdInfo': {'id': 'Mshi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine and Cisplatin', 'description': 'Drug: gemcitabine and cisplatin The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT..', 'interventionNames': ['Drug: gemcitabine and cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'docetaxel and cisplatin', 'description': 'Drug: Docetaxel and cisplatin TP regimen consists of docetaxel at a dose of 75 mg/m2/day on day 1, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.', 'interventionNames': ['Drug: docetaxel and cisplatin']}], 'interventions': [{'name': 'gemcitabine and cisplatin', 'type': 'DRUG', 'otherNames': ['GP'], 'description': 'Drug: gemcitabine and cisplatin The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.', 'armGroupLabels': ['Gemcitabine and Cisplatin']}, {'name': 'docetaxel and cisplatin', 'type': 'DRUG', 'otherNames': ['TP'], 'description': 'Drug: Docetaxel and cisplatin The TP regimen consists of docetaxel at a dose of 75 mg/m2/day on day 1,and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.', 'armGroupLabels': ['docetaxel and cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Department of Radiation Oncology, Xijing Hospital, Fourth Military', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'overallOfficials': [{'name': 'Mei Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'department of radiation oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Professor of Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University', 'investigatorFullName': 'Mei Shi', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}