A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
- Registration Number
- NCT01002092
- Lead Sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
- Brief Summary
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endostar plus Chemotherapy Chemotherapy - Chemotherapy Chemotherapy - Endostar plus Chemotherapy Endostar -
- Primary Outcome Measures
Name Time Method Progression Free Survival 5 years
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years Clinical Response Rate end of the first cycle Limb Salvage Rate end of the first cycle Clinical Benefit Response end of the first cycle Quality of Life after 4 cycles
Trial Locations
- Locations (4)
Nanjing General Hospital of Nanjing Military Command
🇨🇳Nanjing, Jiangsu, China
The Military General Hospital of Beijing PLA
🇨🇳Beijing, China
General Hospital of Jinan Military Command
🇨🇳Jinan, Shandong, China
Xijing Hospital
🇨🇳Xi'an, Shanxi, China