Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma (Li2CO3)
This study is not yet open for participant recruitment.
Verified August 2012 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Collaborators:
Qilu Hospital
Nanfang Hospital,Southern Medical University
Guangdong Hospital of Traditional Chinese Medicine
The First Affiliated Hospital,Shenzhen University
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: August 16, 2012
Last verified: August 2012
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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 Multi-center Clinical Trial of Lithium Carbonate Combined With Neo-adjuvent 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 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- over-all survival,metastasis-free survival [ 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 |
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
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,Southern Medical University
Guangdong Hospital of Traditional Chinese Medicine
The First Affiliated Hospital,Shenzhen University
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: | August 16, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Sun Yat-sen University:
|
Lithium Carbonate Chemotherapy prognosis |
Additional relevant MeSH terms:
|
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Lithium Lithium Carbonate Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013