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Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer

NCT ID: NCT00434668

Last Updated: 2010-11-30

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

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-11-30

Brief Summary

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The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Keywords

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Non-Small Cell Lung Cancer NSCLC Adjuvant chemotherapy for completely resected NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cisplatin/docetaxel

Intervention Type DRUG

cisplatin/vinorelbine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* completely resected pathological stage IB or II NSCLC
* adequate haematological, renal and liver function and condition

Exclusion Criteria

* previous chemo or radiotherapy for NSCLC
* bronchoalveolar cell subtype
* second active primary malignancy or serious concomitant medical disease
* difficulties with adequate follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Thoracale Oncologie Groep Antwerpen

Principal Investigators

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Paul R. Germonpre, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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ZNA Middelheim

Antwerp, Antwerp, Belgium

Site Status

University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status

St Augustinus ziekenhuis

Wilrijk, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Eudra CT 2005-004029-24

Identifier Type: -

Identifier Source: secondary_id

TOGA 0501

Identifier Type: -

Identifier Source: org_study_id