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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Sun Yat-sen University
Sponsor:
Collaborators:
Qilu Hospital
Nanfang Hospital of Southern Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shenzhen Second People's Hospital, The First Affiliated Hospital of 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
  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
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
Guangdong Provincial Hospital of Traditional Chinese Medicine
Shenzhen Second People's Hospital, The First Affiliated Hospital of 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 July 24, 2014