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A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma


Phase 2
12 Years
60 Years
Open (Enrolling)
Both
Osteosarcoma

Thank you

Trial Information

A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Sujia Wu, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nanjing PLA General Hospital

Authority:

China: Ethics Committee

Study ID:

SIM-65

NCT ID:

NCT01002092

Start Date:

February 2009

Completion Date:

December 2014

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma
  • Endostar
  • Chemotherapy
  • Osteosarcoma

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