Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 14, 2012
First Posted Date  ICMJE August 21, 2012
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
progression-free survival,incidence of chemotherapy-induced myelosuppression [ Time Frame: at least 24 months or at most 120 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
progression-free survival,incidence of chemotherapy-induced myelosuppression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
over-all survival,metastasis-free survival [ Time Frame: at least 24 months or at most 120 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
over-all survival,metastasis-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma
Official Title  ICMJE A Prospected Randomized Multicenter Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma
Brief Summary The purpose of this study is to determine whether Lithium Carbonate combined with neo-adjuvant chemotherapy improve the prognosis of osteosarcoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteosarcoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • Experimental: Lithium Carbonate
    Patients in this arm take Lithium Carbonate twice a day with a dose of 20-25mg/kg/d.
    Intervention: Drug: Lithium Carbonate
Publications * Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2012)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jin Wang, PhD +86-20-87755766 ext 8236 2004wjhf@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01669369
Other Study ID Numbers  ICMJE Lithium-5010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Jin Wang, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Jin Wang, PhD First Affiliated Hospital, Sun Yat-Sen University
PRS Account Sun Yat-sen University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP