Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 7:27 PM
Study NCT ID:
NCT01218594
Status:
UNKNOWN
Last Update Posted:
2012-10-17
First Post:
2010-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043169', 'term': 'Endostatins'}, {'id': 'C522911', 'term': 'endostar protein'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chenming@sysucc.org.cn', 'phone': '86-20-87343640', 'title': 'Ming Chen', 'organization': 'Sun Yat-Sen University Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a single-arm study, no comparison between Endostar to CCRT and CCRT alone was performed. It is not clear whether the observed improvement in survival is a result of the addition of Endostar or patient selection.The patient samples are small.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Endostar Plus CCRT', 'description': 'Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\\~66 Gy.', 'otherNumAtRisk': 48, 'otherNumAffected': 48, 'seriousNumAtRisk': 48, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hematologic toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 47, 'numAffected': 47}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 47, 'numAffected': 47}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'special pneumohemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate (RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Endostar Plus CCRT', 'description': 'Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\\~66 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after CCRT', 'description': 'Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response rate (RR)include complete response and partial response.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Endostar Plus CCRT', 'description': 'Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\\~66 Gy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Between May 2009 and January 2012, 50 patients from 5 centers were enrolled onto the study.', 'preAssignmentDetails': 'Two patients refused treatment after consenting for therapy and were ultimately excluded from the trial before any treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Endostar Plus CCRT', 'description': 'Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\\~66 Gy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-17', 'studyFirstSubmitDate': '2010-06-01', 'resultsFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-17', 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate (RR)', 'timeFrame': '4 weeks after CCRT', 'description': 'Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stage III', 'Unresectable', 'Non-small cell lung cancer'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25497558', 'type': 'DERIVED', 'citation': 'Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).', 'detailedDescription': 'OBJECTIVES:\n\nPrimary:To assess the treatment response rate (RR) of Endostar in combination with CCRT\n\nSecondary\n\n* The progression-free survival (PFS)\n* The overall survival(OS).\n* The failed treatment modality.\n* The toxicity of this regimen.\n\nOUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration\\>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.\n\nEndostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.\n\nPatients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n\n * untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC\n * weight loss of less than 10% in the past 6 months\n * performance status (PS) of 0 to 1\n * forced vital capacity in 1 second (FEV1) higher than 0.8 L\n * measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).\n * absolute neutrophil count (ANC) of ≥ 1500/μL\n * hemoglobin ≥ 10 mg/dL\n * platelet ≥ 100,000/μL\n * serum creatinine ≤ 1.25 times of upper limit of normal (ULN)\n * calculated creatinine clearance (CrCl) of ≥ 60 ml/min\n * bilirubin 1.5×ULN\n * AST and ALT less than 2.5×ULN\n * alkaline phosphatase less than 5×ULN.\n\nExclusion Criteria:\n\n* active infection\n* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)\n* malnutrition (loss of ≥ 20% of the original body weight)\n* sensor or motor neuropathy \\> grade I\n* second primary malignancy, except for non-melanoma skin cancer\n* psychiatric illness or social situation that would preclude study compliance\n* pregnant or lactating women\n* preexisting bleeding diatheses or coagulopathy\n* Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway'}, 'identificationModule': {'nctId': 'NCT01218594', 'acronym': 'DP-EN-RT', 'briefTitle': 'Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'DP-EN-RT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostatin combine CCRT', 'description': '7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks', 'interventionNames': ['Drug: Endostatin']}], 'interventions': [{'name': 'Endostatin', 'type': 'DRUG', 'otherNames': ['Endostar'], 'description': '7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks', 'armGroupLabels': ['Endostatin combine CCRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Ming Chen, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Hospital of Guangdong Medical University', 'class': 'OTHER'}, {'name': 'Fujian Province Tumor Hospital', 'class': 'OTHER'}, {'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'The Affiliated Tumor Hospital of Guangxi Medical University', 'class': 'UNKNOWN'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Guangzhou General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, {'name': 'The 458 Hospital of Chinese PLA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ming Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}