Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma (Li2CO3)
The purpose of this study is to determine whether Lithium Carbonate combined with neo-adjuvant chemotherapy improve the prognosis of osteosarcoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospected Randomized Multicenter Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma|
- progression-free survival,incidence of chemotherapy-induced myelosuppression [ Time Frame: at least 24 months or at most 120 months ] [ Designated as safety issue: Yes ]
- over-all survival,metastasis-free survival [ Time Frame: at least 24 months or at most 120 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2023|
|Estimated Primary Completion Date:||December 2023 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
The shape,color and smell of placebo are similar to Lithium Carbonate tablet used in the treatment arm.Patients in this arm take placebo twice a day.
Experimental: Lithium Carbonate
Patients in this arm take Lithium Carbonate twice a day with a dose of 20-25mg/kg/d.
Drug: Lithium Carbonate
400 patients were randomly divided into two groups according to sequence of entering the group: lithium carbonate group and control group (1:1). Patients in lithium carbonate group were treated with combinations of chemotherapy and lithium carbonate, the control group were treated with chemotherapy only. Patients were suggesting continuing this trial until the end of the chemotherapy regimen or being confirmed as disease progression by RECIST.
Other Name: Lithobid
Osteosarcoma is the most common primary malignant bone tumor in childhood and adolescence, the prognosis for the disease is poor. What's more, chemotherapy resistance and serious myelosuppression occur frequently in clinical further hindered canonical adjuvant chemotherapy. In our previous researches, we observed that GSK-3B positively regulates the NF-kB pathway to promote proliferation and tumorigenicity in osteosarcoma cell. Targeted inhibition of GSK3beta showed an obvious antitumor effect. It is a promising therapeutic target in osteosarcoma, especially if GSK-3b inhibition is combined with chemotherapeutic drugs. Lithium carbonate, commonly use in clinical application because of its fine quality and cheap price, was proven to be effected as a kind of GSK3beta inhibitor and stimulating factor of peripheral blood leukocyte. Therefore, lithium carbonate theoretically possesses effects of both anti-tumor as well as improvement of myelosuppression. We look forward to the results of clinical trials to test the effect of combinations of chemical drugs with lithium carbonate on myelosuppression, disease-free survival rate and lung metastasis rate in patients with osteosarcoma who treated with conventional chemotherapeutic regimens and wide resection. This study is a multi-centre, double-blind, randomized clinical trial phase 4. The inclusion criterion is patients with primary osteosarcoma in femur, tibia and humerus（IIB）. With the help of statistic method, 400 patients were randomly divided into two groups according to sequence of entering the group: lithium carbonate group and control group (1:1). Patients were suggesting continuing this trial until the end of the chemotherapy regimen or being confirmed as disease progression by RECIST guiding principles. According to their histological types, patients are analyzed using subgroup analysis. Disease evaluation will be conducted every 8 weeks. A follow-up to count the overall survival rate after grouping was performed within at least 24 months or at most 120 months. Our study may represent a novel and feasible approach by combination of conventional chemotherapy drugs and targeted drugs. More importantly, it may hopefully be a promising strategy to improve overall survival of osteosarcoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669369
|Contact: Jin Wang, PhD||+86-20-87755766 ext firstname.lastname@example.org|
|The first affiliated hospital,Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Jin Wang, PhD +86-87755766 ext 8236 email@example.com;firstname.lastname@example.org|
|Principal Investigator: Jin Wang, PhD|
|The first affiliated hospital,Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Jin Wang, PhD +86-20-87755766 ext 8236|
|Principal Investigator:||Jin Wang, PhD||First Affiliated Hospital, Sun Yat-Sen University|