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A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Primary Purpose

Osteosarcoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Endostar
Sponsored by
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring Osteosarcoma, Endostar, Chemotherapy

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing General Hospital of Nanjing Military Command
  • General Hospital of Jinan Military Command
  • Xijing Hospital
  • The Military General Hospital of Beijing PLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy

Endostar plus Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Limb Salvage Rate
Overall Survival
Clinical Response Rate
Clinical Benefit Response
Quality of Life

Full Information

First Posted
October 25, 2009
Last Updated
August 31, 2014
Sponsor
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01002092
Brief Title
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Official Title
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
Osteosarcoma, Endostar, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Title
Endostar plus Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Endostar
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Limb Salvage Rate
Time Frame
end of the first cycle
Title
Overall Survival
Time Frame
5 years
Title
Clinical Response Rate
Time Frame
end of the first cycle
Title
Clinical Benefit Response
Time Frame
end of the first cycle
Title
Quality of Life
Time Frame
after 4 cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujia Wu, Dr.
Organizational Affiliation
Nanjing PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Shi, Dr.
Organizational Affiliation
Nanjing PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
General Hospital of Jinan Military Command
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
The Military General Hospital of Beijing PLA
City
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

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