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A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy

NCT ID: NCT01758666

Last Updated: 2015-12-22

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-12-31

Brief Summary

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At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma.

Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.

Detailed Description

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Conditions

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Osteosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methotrexate and Calcium folinate

Group Type EXPERIMENTAL

Methotrexate,Calcium folinate

Intervention Type DRUG

Interventions

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Methotrexate,Calcium folinate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Proved by pathology in 60 cases of osteosarcoma patients
2. PS ≤ 2, survival period is more than 6 months
3. Normal function of liver and kidney
4. No chemotherapy contraindication, patients treat with high dose methotrexate
5. Get signed written informed consent form
6. Have a good compliance with take blood and follow-up
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen Wang

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Other Identifiers

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CIH-WAC-201205001

Identifier Type: -

Identifier Source: org_study_id