Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-10 @ 11:32 PM
Study NCT ID:
NCT01915134
Status:
UNKNOWN
Last Update Posted:
2015-01-01
First Post:
2013-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostatin in Combination With Chemotherapy for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043169', 'term': 'Endostatins'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D043165', 'term': 'Angiostatic Proteins'}, {'id': 'D042501', 'term': 'Angiogenic Proteins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043170', 'term': 'Collagen Type XVIII'}, {'id': 'D024041', 'term': 'Non-Fibrillar Collagens'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 362}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-30', 'studyFirstSubmitDate': '2013-07-21', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2015-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The quality of life assessment', 'timeFrame': 'participants will be followed for the duration of hospital stay,an expected average of 100 days and every 6 months thereafter for 3 years', 'description': 'According to the most commonly used questionnaire EORTC QLQ C30 and H\\&N35 35 for evaluation'}], 'primaryOutcomes': [{'measure': 'progress free survival(PFS)', 'timeFrame': '2years after the inception assignment', 'description': 'PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.'}], 'secondaryOutcomes': [{'measure': 'overall survival(OS)', 'timeFrame': '1 year ,2 years and 3 years after the inception of the assignment', 'description': 'the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.'}, {'measure': 'Adverse events', 'timeFrame': 'participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years', 'description': 'observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nasopharyngeal carcinoma', 'Recombinant Human Endostatin', 'chemotherapy', 'gemcitabine and cisplatin'], 'conditions': ['Effects of Chemotherapy', 'Stage IVC Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).', 'detailedDescription': 'To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.\n\nExclusion Criteria:\n\n* To give local treatment,clinical severe infection(\\>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.'}, 'identificationModule': {'nctId': 'NCT01915134', 'briefTitle': 'Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage Ⅲ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'ZhejaingCH-npc-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EGP group', 'description': 'the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy', 'interventionNames': ['Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GP group', 'description': 'the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy', 'interventionNames': ['Drug: Gemcitabine and cisplatin']}], 'interventions': [{'name': 'Recombinant Human Endostatin plus gemcitabine and cisplatin', 'type': 'DRUG', 'otherNames': ['Experimental: EGP group'], 'description': 'target therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.', 'armGroupLabels': ['EGP group']}, {'name': 'Gemcitabine and cisplatin', 'type': 'DRUG', 'otherNames': ['No Intervention: GP group'], 'description': 'only chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.', 'armGroupLabels': ['GP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Li', 'role': 'CONTACT', 'email': 'libindoctor@163.com', 'phone': '86-571-88122091'}, {'name': 'Xinglai Feng', 'role': 'CONTACT', 'email': 'fengxinglai@hotmail.com', 'phone': '86-571-88122092'}, {'name': 'Bin Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiaozhong Chen', 'role': 'CONTACT', 'email': 'cxzfyun@sina.com', 'phone': '86-571-88122098'}, {'name': 'Bin Li', 'role': 'CONTACT', 'email': 'libindoctor@163.com', 'phone': '86-571-88122091'}], 'overallOfficials': [{'name': 'Xiaozhong Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}, {'name': 'Xiaozhong Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}