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

NCT ID: NCT01669369

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteosarcoma

Keywords

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Lithium Carbonate Chemotherapy prognosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Lithium Carbonate

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

Group Type EXPERIMENTAL

Lithium Carbonate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Lithobid PLACEBO TREATMENT

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Jin Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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The first affiliated hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin Wang, PhD

Role: CONTACT

Phone: +86-20-87755766

Email: [email protected]

Facility Contacts

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Jin Wang, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31401903 (View on PubMed)

Other Identifiers

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Lithium-5010

Identifier Type: -

Identifier Source: org_study_id