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