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

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ClinicalTrials.gov Identifier: NCT01669369
Recruitment Status : Recruiting
First Posted : August 21, 2012
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Qilu Hospital of Shandong University
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

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

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: Lithium Carbonate Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.
Other Name: PLACEBO TREATMENT
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


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival,incidence of chemotherapy-induced myelosuppression [ Time Frame: at least 24 months or at most 120 months ]

Secondary Outcome Measures :
  1. over-all survival,metastasis-free survival [ Time Frame: at least 24 months or at most 120 months ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669369


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

Locations
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China, Guangdong
The first affiliated hospital,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Jin Wang, PhD    +86-20-87755766 ext 8236    2004wjhf@163.com;viewrine@qq.com   
Principal Investigator: Jin Wang, PhD         
Sponsors and Collaborators
Sun Yat-sen University
Qilu Hospital of Shandong University
Nanfang Hospital of Southern Medical University
Shenzhen Second People's Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shanghai 6th People's Hospital
Investigators
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Principal Investigator: Jin Wang, PhD First Affiliated Hospital, Sun Yat-Sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jin Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01669369    
Other Study ID Numbers: Lithium-5010
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Because our research has not yet finished, we would decide whether or not make individual participant data (IPD) available to other researchers according to the result of this study.
Keywords provided by Jin Wang, Sun Yat-sen University:
Lithium Carbonate
Chemotherapy
prognosis
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Lithium Carbonate
 Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs