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Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00154739

Last Updated: 2008-08-04

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.

Detailed Description

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Most patients suffered from nausea, vomiting and prolonged anorexia after cisplatin treatment. Epirubicin is an anthracycline that was used widely in the treatment of cancer. Our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer patients showed a response rate of 52.6% and good median survival. However, most patients suffered from paclitaxel-related neurotoxicity.

Chemotherapy may increase an average of 1 to 2 months of median survival in inoperable non-small cell lung cancer patients treated with chemotherapy. However, chemotherapy may not provide a cure for these patients. Reduction of side effects and enhancement of life quality of the patients are as important as life prolongation for these patients. We designed a combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable non-small cell lung cancer. The treatment will be compared to gemcitabine and cisplatin combination.

Conditions

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Non-Small Cell Lung Cancer

Keywords

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Combination, Chemotherapy,non-small cell lung cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
* No prior chemotherapy
* Age \> 18 years
* ECOG score \< 0 to 2
* Bi-dimensionally measurable lesions
* WBC \> 4,000/ml, ANC \> 1,500/ml, platelets\>100,000/ml
* Hb\>10g/dl.
* ALT/AST \< 5 times x UNL, bilirubin \< 1.5times x UNL, creatinine \< 1.25 times x UNL, normal calcium level
* Life expectancy \> 12 weeks

Exclusion Criteria

* CNS metastases, Concomitant myelosuppressive radiotherapy, C/T, hormonal therapy or immunotherapy.
* Active congestive heart failure, angina and/or arrhythmia requiring therapy or previous myocardial infarction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Chin-Hsin Yang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, National Taiwan University Hospital

Ann-Lii Cheng, M.D., Ph.D.

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

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Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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46S1

Identifier Type: -

Identifier Source: org_study_id