A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
NCT ID: NCT01002092
Last Updated: 2014-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2009-02-28
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endostar Combined With AI Regimen Compared With AI in Adjuvant Treatment
NCT04699214
Chemotherapy for Patients With Osteosarcoma
NCT00523419
Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade, Operable, Non-metastatic Osteosarcoma of the Extremity
NCT02273583
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
NCT00134030
Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma
NCT00742924
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chemotherapy
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).
Endostar plus Chemotherapy
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).
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Serious infection
* Evidence of bleeding diathesis
* Significant cardiovascular disease
* Pregnant or lactating woman
* Allergic to E.coli preparation
12 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sujia Wu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nanjing PLA General Hospital
Xin Shi, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nanjing PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
General Hospital of Jinan Military Command
Jinan, Shandong, China
Xijing Hospital
Xi’an, Shanxi, China
The Military General Hospital of Beijing PLA
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SIM-65
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.