A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
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ClinicalTrials.gov Identifier: NCT01002092 |
Recruitment Status : Unknown
Verified August 2014 by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd.
Recruitment status was: Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : September 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteosarcoma | Drug: Chemotherapy Drug: Endostar | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | December 2014 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Chemotherapy |
Drug: Chemotherapy
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). |
Experimental: Endostar plus Chemotherapy |
Drug: Chemotherapy
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). Drug: Endostar 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 |
- Progression Free Survival [ Time Frame: 5 years ]
- Limb Salvage Rate [ Time Frame: end of the first cycle ]
- Overall Survival [ Time Frame: 5 years ]
- Clinical Response Rate [ Time Frame: end of the first cycle ]
- Clinical Benefit Response [ Time Frame: end of the first cycle ]
- Quality of Life [ Time Frame: after 4 cycles ]

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Ages Eligible for Study: | 12 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002092
China, Jiangsu | |
Nanjing General Hospital of Nanjing Military Command | |
Nanjing, Jiangsu, China, 210002 | |
China, Shandong | |
General Hospital of Jinan Military Command | |
Jinan, Shandong, China, 250031 | |
China, Shanxi | |
Xijing Hospital | |
Xi'an, Shanxi, China, 710032 | |
China | |
The Military General Hospital of Beijing PLA | |
Beijing, China, 100700 |
Principal Investigator: | Sujia Wu, Dr. | Nanjing PLA General Hospital | |
Principal Investigator: | Xin Shi, Dr. | Nanjing PLA General Hospital |
Responsible Party: | Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT01002092 |
Other Study ID Numbers: |
SIM-65 |
First Posted: | October 27, 2009 Key Record Dates |
Last Update Posted: | September 3, 2014 |
Last Verified: | August 2014 |
Osteosarcoma Endostar Chemotherapy |
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma |
Endostar protein Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |