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Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

NCT ID: NCT00172380

Last Updated: 2012-12-20

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2010-03-31

Brief Summary

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To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.

Detailed Description

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Conditions

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NSCLC

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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docetaxel and cisplatin

docetaxel 36mg/m2 and cisplatin 75mg/m2

Group Type EXPERIMENTAL

Docetaxel Plus CDDP

Intervention Type DRUG

docetaxel 36mg/m2 and cisplatin 75mg/m2

Interventions

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Docetaxel Plus CDDP

docetaxel 36mg/m2 and cisplatin 75mg/m2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2 or or unresectable stage IIIb 2.KPS\>70% 3.Hb\>10g/dl,ANC\>2.0x109/L,Plt.\>100x109/L4.T-bil.\<1xULN,creatinine\<1xULN,creatinine clearance \>60 ml/min,GPT/GOT\<2.5xULN,ALP\<5xULN

Exclusion Criteria

* 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chong-Jen Yu, M.D,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, National Taiwan University hospital

Locations

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Department of Internal Medicine, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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930911

Identifier Type: -

Identifier Source: org_study_id