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A Prospected Randomized Multi-center Clinical Trial of Lithium Carbonate Combined With Neo-adjuvent Chemotherapy to Treat Osteosarcoma


Phase 4
8 Years
70 Years
Not Enrolling
Both
Osteosarcoma

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Trial Information

A Prospected Randomized Multi-center Clinical Trial of Lithium Carbonate Combined With Neo-adjuvent Chemotherapy to Treat Osteosarcoma


Inclusion Criteria:



- histologically diagnosed primary classical osteosarcoma in extremities

- staging IIB

- MRI showing no skip lesion

- receive standard neo-adjuvant chemotherapy, adjuvant chemotherapy,and standard
surgical treatment

Exclusion Criteria:

- a history of non-standard treatment(chemotherapy or surgery)

- secondary osteosarcoma or well-differentiated parosteal osteosarcoma

- evident dysfunction of cardia,liver and kidney, or pregnant women or women during
lactation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

progression-free survival,incidence of chemotherapy-induced myelosuppression

Safety Issue:

Yes

Principal Investigator

Jin Wang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Affiliated Hospital, Sun Yat-Sen University

Authority:

China: Ethics Committee

Study ID:

Lithium-5010

NCT ID:

NCT01669369

Start Date:

January 2013

Completion Date:

December 2023

Related Keywords:

  • Osteosarcoma
  • Lithium Carbonate
  • Chemotherapy
  • prognosis
  • Osteosarcoma

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