NCT01002092
Unknown
Phase 2
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd4 sites in 1 country160 target enrollmentFebruary 2009
Overview
- Phase
- Phase 2
- Intervention
- Endostar
- Conditions
- Osteosarcoma
- Sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
- Enrollment
- 160
- Locations
- 4
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 11 years ago
Overview
Brief Summary
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
Investigators
Eligibility Criteria
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
Arms & Interventions
Endostar plus Chemotherapy
Intervention: Endostar
Chemotherapy
Intervention: Chemotherapy
Endostar plus Chemotherapy
Intervention: Chemotherapy
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 5 years
Secondary Outcomes
- Clinical Response Rate(end of the first cycle)
- Overall Survival(5 years)
- Limb Salvage Rate(end of the first cycle)
- Clinical Benefit Response(end of the first cycle)
- Quality of Life(after 4 cycles)
Study Sites (4)
Loading locations...
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