Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma

Osteosarcoma Clinical Trial

— Li2CO3  

Official title:

A Prospected Randomized Multicenter Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01669369
• Other study ID #: Lithium-5010
• Status: Recruiting
• Phase: Phase 4
• First received: August 14, 2012
• Last updated: October 31, 2016
• Start date: January 2013
• Est. completion date: December 2023

Study information

• Verified date: October 2016
• Source: Sun Yat-sen University
• Contact: Jin Wang, PhD
• Phone: +86-20-87755766
• Email: 2004wjhf[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Lithium Carbonate combined with neo-adjuvant chemotherapy improve the prognosis of osteosarcoma

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The first affiliated hospital,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangdong Provincial Hospital of Traditional Chinese Medicine, Nanfang Hospital of Southern Medical University, Qilu Hospital, Shanghai 6th People's Hospital, Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival,incidence of chemotherapy-induced myelosuppression		at least 24 months or at most 120 months	Yes
Secondary	over-all survival,metastasis-free survival		at least 24 months or at most 120 months	No