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

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.
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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.
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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 |
- progression-free survival,incidence of chemotherapy-induced myelosuppression [ Time Frame: at least 24 months or at most 120 months ]
- over-all survival,metastasis-free survival [ Time Frame: at least 24 months or at most 120 months ]

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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 |
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

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
Contact: Jin Wang, PhD | +86-20-87755766 ext 8236 | 2004wjhf@163.com |
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 |
Principal Investigator: | Jin Wang, PhD | First Affiliated Hospital, Sun Yat-Sen University |
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. |
Lithium Carbonate Chemotherapy prognosis |
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Lithium Carbonate |
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