Osteosarcoma
Conditions
Keywords
Osteosarcoma, Endostar, Chemotherapy
Brief summary
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
Interventions
DRUGChemotherapy
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).
DRUGEndostar
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
Sponsors
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Limb Salvage Rate | end of the first cycle |
| Overall Survival | 5 years |
| Clinical Response Rate | end of the first cycle |
| Clinical Benefit Response | end of the first cycle |
| Quality of Life | after 4 cycles |
Countries
China
Outcome results
None listed