Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer (IRESSA&H&N)

September 21, 2010 updated by: AstraZeneca

Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial

To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Bern, Switzerland
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Age over 18 years
  • Histologically proven squamous cell cancer of the head & neck (SCCHN)
  • Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3

Exclusion Criteria:

  • Hypersensitivity to ZD1839 or any of the excipients of this product
  • Tumour stage M1
  • Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
  • Absolute neutrophil counts <1.5 x 109

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
post operative combination of gefinib and RT
Drug: Gefitinib
250 mg; oral
Other Names:
  • IRESSA (TM)
Drug: Gefitinib
250mg; oral
Other Names:
  • IRESSA (TM)
Experimental: Cohort 2
combination of gefitinib with RT and Chemotherapy in non operated patients
Drug: Gefitinib
250 mg; oral
Other Names:
  • IRESSA (TM)
Drug: Gefitinib
250mg; oral
Other Names:
  • IRESSA (TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa

Secondary Outcome Measures

Outcome Measure
Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
Cohort 1 only time-to-recurrence (TTR)
Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Christoph Rochlitz, Prof Dr med, University Hospital of Basel
  • Study Director: Madeleine Billeter, MD, AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
  • Study Chair: Verena Renggli, AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0525

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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