Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

NCT ID: NCT00233636

Last Updated: 2011-01-27

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

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Brief Summary

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The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Detailed Description

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Conditions

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Head and Neck Cancer Carcinoma, Squamous Cell

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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Iressa (Gefitinib)

Intervention Type DRUG

Radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
* At least one measurable tumour lesion

Exclusion Criteria

* No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
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 Italy Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Aviano, , Italy

Site Status

Research Site

Azienda, , Italy

Site Status

Research Site

Milan, , Italy

Site Status

Research Site

Napoli, , Italy

Site Status

Research Site

Palermo, , Italy

Site Status

Research Site

Ragusa, , Italy

Site Status

Countries

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Italy

Other Identifiers

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1839IL/0070

Identifier Type: -

Identifier Source: org_study_id

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