The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

NCT ID: NCT01797913

Last Updated: 2016-02-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer

Detailed Description

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Conditions

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THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

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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gemcitabine

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

gemcitabine,1000mg/m2,ivgtt,DAY1\&DAY8

Interventions

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gemcitabine

gemcitabine,1000mg/m2,ivgtt,DAY1\&DAY8

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

18\~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy.

3\~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes

Normal laboratory values:

* leucocyte ≥ 4×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent

Exclusion Criteria

* Patients have used drugs according to protocol
* Uncontrolled infection of Bacterial or virus or fungal
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Female patients during their pregnant and lactation period, or patients without contracep
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Chang Jian Hua

Vice director of department of chemotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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GEM-CJH

Identifier Type: -

Identifier Source: org_study_id

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