NCT01669369

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

10.9 years

First QC Date

August 14, 2012

Last Update Submit

October 31, 2016

Conditions

Osteosarcoma

Keywords

Lithium CarbonateChemotherapyprognosis

Outcome Measures

Primary Outcomes (1)

  • progression-free survival,incidence of chemotherapy-induced myelosuppression

    at least 24 months or at most 120 months

Secondary Outcomes (1)

  • over-all survival,metastasis-free survival

    at least 24 months or at most 120 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Lithium Carbonate

EXPERIMENTAL

Patients in this arm take Lithium Carbonate twice a day with a dose of 20-25mg/kg/d.

Drug: Lithium Carbonate

Interventions

Lithium CarbonateDRUG

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.

Also known as: Lithobid
Lithium Carbonate
PlaceboDRUG

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.

Also known as: PLACEBO TREATMENT
Placebo

Eligibility Criteria

Age8 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31401903DERIVED

MeSH Terms

Conditions

Osteosarcoma

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Officials

  • Jin Wang, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Wang, PhD

CONTACT

+86-20-877557662004wjhf@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 21, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

CN(1)