A Study of Endostar Combined With Chemotherapy for Treatm... | NCT01002092

Studies
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

NCT01002092

Sponsor

Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Status

Unknown status

Last Update Posted

Sep 3, 2014Estimated

Enrollment

160Estimated

Phase

Phase 2

Conditions

Osteosarcoma

Interventions

Chemotherapy
Endostar

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Oct 25, 2009

First Submission Date that Met QC Criteria

Oct 25, 2009

First Posted Date

Oct 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2014

Last Update Posted Date

Sep 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemotherapy	Active Comparator		Drug: Chemotherapy
Endostar plus Chemotherapy	Experimental		Drug: Chemotherapy Drug: Endostar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy	Drug	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival		5 years

Secondary Outcomes

Measure	Description	Time Frame
Limb Salvage Rate		end of the first cycle
Overall Survival		5 years
Clinical Response Rate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sujia Wu, Dr.	Nanjing PLA General Hospital	Principal Investigator
Xin Shi, Dr.	Nanjing PLA General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing General Hospital of Nanjing Military Command		Nanjing	Jiangsu	210002	China
General Hospital of Jinan Military Command

Condition Browse Module

MeSH Terms

ID	Term
D012516	Osteosarcoma

Ancestor Terms

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004358	Drug Therapy
C522911	endostar protein

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided