A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
1 other identifier
interventional
160
1 country
4
Brief Summary
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 25, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 3, 2014
August 1, 2014
5.8 years
October 25, 2009
August 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
5 years
Secondary Outcomes (5)
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
Study Arms (2)
Chemotherapy
ACTIVE COMPARATOREndostar plus Chemotherapy
EXPERIMENTALInterventions
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).
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
You may qualify if:
- 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
You may not qualify if:
- Evidence of metastasis
- Serious infection
- Evidence of bleeding diathesis
- Significant cardiovascular disease
- Pregnant or lactating woman
- Allergic to E.coli preparation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, 210002, China
General Hospital of Jinan Military Command
Jinan, Shandong, 250031, China
Xijing Hospital
Xi’an, Shanxi, 710032, China
The Military General Hospital of Beijing PLA
Beijing, 100700, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sujia Wu, Dr.
Nanjing PLA General Hospital
- PRINCIPAL INVESTIGATOR
Xin Shi, Dr.
Nanjing PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2009
First Posted
October 27, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 3, 2014
Record last verified: 2014-08