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

NCT01669369 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-11-01

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jin Wang, PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01669369 on ClinicalTrials.gov