Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 9:53 PM
Study NCT ID:
NCT01002092
Status:
UNKNOWN
Last Update Posted:
2014-09-03
First Post:
2009-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'C522911', 'term': 'endostar protein'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-31', 'studyFirstSubmitDate': '2009-10-25', 'studyFirstSubmitQcDate': '2009-10-25', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Limb Salvage Rate', 'timeFrame': 'end of the first cycle'}, {'measure': 'Overall Survival', 'timeFrame': '5 years'}, {'measure': 'Clinical Response Rate', 'timeFrame': 'end of the first cycle'}, {'measure': 'Clinical Benefit Response', 'timeFrame': 'end of the first cycle'}, {'measure': 'Quality of Life', 'timeFrame': 'after 4 cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteosarcoma', 'Endostar', 'Chemotherapy'], 'conditions': ['Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis\n* At least one measurable lesion\n* Life expectancy \\> 3 months\n* ECOG performance status 0-2\n* Adequate hematologic, cardiac, renal, and hepatic function\n* Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study\n\nExclusion Criteria:\n\n* Evidence of metastasis\n* Serious infection\n* Evidence of bleeding diathesis\n* Significant cardiovascular disease\n* Pregnant or lactating woman\n* Allergic to E.coli preparation'}, 'identificationModule': {'nctId': 'NCT01002092', 'briefTitle': 'A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma', 'orgStudyIdInfo': {'id': 'SIM-65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'interventionNames': ['Drug: Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Endostar plus Chemotherapy', 'interventionNames': ['Drug: Chemotherapy', 'Drug: Endostar']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).', 'armGroupLabels': ['Chemotherapy', 'Endostar plus Chemotherapy']}, {'name': 'Endostar', 'type': 'DRUG', 'description': 'In each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day', 'armGroupLabels': ['Endostar plus Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing General Hospital of Nanjing Military Command', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '250031', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'General Hospital of Jinan Military Command', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '100700', 'city': 'Beijing', 'country': 'China', 'facility': 'The Military General Hospital of Beijing PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Sujia Wu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing PLA General Hospital'}, {'name': 'Xin Shi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}