Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma (Li2CO3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sun Yat-sen University
Sponsor:
Collaborators:
Qilu Hospital
Nanfang Hospital of Southern Medical University
Shenzhen Second People's Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shanghai 6th People's Hospital
Information provided by (Responsible Party):
Jin Wang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01669369
First received: August 14, 2012
Last updated: December 1, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Osteosarcoma
Drug: Lithium Carbonate
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • progression-free survival,incidence of chemotherapy-induced myelosuppression [ Time Frame: at least 24 months or at most 120 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • over-all survival,metastasis-free survival [ Time Frame: at least 24 months or at most 120 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
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)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669369

Contacts
Contact: Jin Wang, PhD +86-20-87755766 ext 8236 2004wjhf@163.com

Locations
China, Guangdong
The first affiliated hospital,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Jin Wang, PhD    +86-87755766 ext 8236    2004wjhf@163.com;viewrine@qq.com   
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      
Sponsors and Collaborators
Sun Yat-sen University
Qilu Hospital
Nanfang Hospital of Southern Medical University
Shenzhen Second People's Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shanghai 6th People's Hospital
Investigators
Principal Investigator: Jin Wang, PhD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Jin Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01669369     History of Changes
Other Study ID Numbers: Lithium-5010
Study First Received: August 14, 2012
Last Updated: December 1, 2014
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Lithium Carbonate
Chemotherapy
prognosis

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Lithium
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on August 27, 2015