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Phase II Iressa + Irradiation Followed by Chemo in NSCLC

NCT ID: NCT00333294

Last Updated: 2007-12-19

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-01-31

Brief Summary

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The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Intervention Type DRUG

Radiation therapy

Intervention Type PROCEDURE

Cisplatin

Intervention Type DRUG

Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* 18 to 75 years inclusive.
* At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
* WHO performance status of 0 to 2 inclusive.
* Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
* Life expectancy of at least 6 months.
* Using secure contraceptives precautions.

Exclusion Criteria

* Any previous anti cancer therapy for NSCLC.
* Known severe hypersensitivity to these products
* Any evidence of clinically active interstitial lung disease
* Other co-existing malignancies, symptomatic metastases.
* Abnormal blood test
* Weight loss of over 15% in the 3 months before the start of the study.
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca France Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Clermont-Ferrand, , France

Site Status

Research Site

Grenoble, , France

Site Status

Research Site

Nantes, , France

Site Status

Research SIte

Paris, , France

Site Status

Countries

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France

Other Identifiers

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1839IL/0530

Identifier Type: -

Identifier Source: org_study_id