Osteosarcoma Clinical Trial
Official title:
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis - At least one measurable lesion - Life expectancy > 3 months - ECOG performance status 0-2 - Adequate hematologic, cardiac, renal, and hepatic function - Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study Exclusion Criteria: - Evidence of metastasis - Serious infection - Evidence of bleeding diathesis - Significant cardiovascular disease - Pregnant or lactating woman - Allergic to E.coli preparation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The Military General Hospital of Beijing PLA | Beijing | |
China | General Hospital of Jinan Military Command | Jinan | Shandong |
China | Nanjing General Hospital of Nanjing Military Command | Nanjing | Jiangsu |
China | Xijing Hospital | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | 5 years | No | |
Secondary | Limb Salvage Rate | end of the first cycle | No | |
Secondary | Overall Survival | 5 years | No | |
Secondary | Clinical Response Rate | end of the first cycle | No | |
Secondary | Clinical Benefit Response | end of the first cycle | No | |
Secondary | Quality of Life | after 4 cycles | No |
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