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The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

NCT ID: NCT00255476

Last Updated: 2009-04-23

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-07-31

Brief Summary

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The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination

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Detailed Description

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Conditions

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Squamous Cell Cancer Cancer of Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gefitinib

Intervention Type DRUG

cisplatin

Intervention Type DRUG

5-flourouracil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* Patients with histologically proven primary SCCHN
* Aged 18 or over

Exclusion Criteria

* Patients eligible for surgery with curative intent
* Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Exclude UCNT
Minimum Eligible Age

18 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 Iressa Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1839IL/0544

Identifier Type: -

Identifier Source: org_study_id

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