Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT01192633
Status:
UNKNOWN
Last Update Posted:
2010-09-01
First Post:
2010-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-31', 'studyFirstSubmitDate': '2010-03-25', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival(Progression-free survival was evaluated for the period from the date of first treatment with this regimen to the date when disease progression was first observed or death occurred.)', 'timeFrame': 'every 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': 'every 6 weeks'}, {'measure': 'Overall Survival', 'timeFrame': '2 years'}, {'measure': 'Side Effects', 'timeFrame': 'every 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcoma', 'gemcitabine', 'vincristine', 'cisplatin', 'chemotherapy'], 'conditions': ['Sarcoma', 'Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '11481354', 'type': 'RESULT', 'citation': 'Patel SR, Gandhi V, Jenkins J, Papadopolous N, Burgess MA, Plager C, Plunkett W, Benjamin RS. Phase II clinical investigation of gemcitabine in advanced soft tissue sarcomas and window evaluation of dose rate on gemcitabine triphosphate accumulation. J Clin Oncol. 2001 Aug 1;19(15):3483-9. doi: 10.1200/JCO.2001.19.15.3483.'}, {'pmid': '16133789', 'type': 'RESULT', 'citation': 'Hartmann JT, Oechsle K, Huober J, Jakob A, Azemar M, Horger M, Kanz L, Bokemeyer C. An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma. Invest New Drugs. 2006 May;24(3):249-53. doi: 10.1007/s10637-005-3537-1.'}, {'pmid': '26512574', 'type': 'DERIVED', 'citation': 'Luo Z, Zhang X, Peng W, Wu X, Wang H, Yu H, Wang J, Chang J, Hong X. A Phase II Study of Gemcitabine, Vincristine, and Cisplatin As Second-Line Treatment for Patients with Advanced Soft Tissue Sarcoma. Medicine (Baltimore). 2015 Oct;94(43):e1777. doi: 10.1097/MD.0000000000001777.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice\n* Be female of male and ≥18 and ≤75 years of age\n* Be ambulatory and have ECOG performance status of ≤1\n* Have histological confirmed sarcoma\n* Locally advanced or metastatic sarcoma who receive first-line chemotherapy.\n* Have at least one target lesion according to the RECIST criteria.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* patient has received chemotherapy drugs including gemcitabine,vincristine and cisplatin\n* Chemotherapy within four weeks preceding treatment start\n* ECOG ≥ 2\n* Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy\n* Participation in any investigational drug study within 4 weeks preceding treatment start\n* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix .Abnormal laboratory values: hemoglobin \\< 8. 0g/dl, neutrophil\\< 1.5×109/L, platelet\\< 100×109/L.\n* serum creatine \\> upper limit of normal (ULN)\n* serum bilirubin \\> ULN\n* alanine aminotransferase(ALT) and aspartate aminotransferase(AST)\\>5×ULN\n* alkaline phosphatase(AKP)\\>5×ULN\n* Serious uncontrolled intercurrence infection\n* Life expectancy of less than 3 months'}, 'identificationModule': {'nctId': 'NCT01192633', 'acronym': 'GVPS', 'briefTitle': 'Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma', 'orgStudyIdInfo': {'id': 'GVP-SAR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GVP', 'type': 'DRUG', 'description': "Drug: gemcitabine, vincristine,cisplatin\n\ncisplatin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 vincristine 1.4mg/m2(less than 2 mg), iv, D1 repeat every 3 weeks"}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiguo Luo, PhD', 'role': 'CONTACT'}, {'name': 'Zhiyu Chen, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhiguo Luo, PhD', 'role': 'CONTACT', 'email': 'luozhiguo88@yahoo.com.cn', 'phone': '862164175590', 'phoneExt': '8908'}], 'overallOfficials': [{'name': 'Xiaonan Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Base for drug clinical trials, Fudan University cancer hospital', 'oldOrganization': 'Fudan University cancer hospital'}}}}