Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

May 20, 2008

Last Updated Date

May 20, 2008

Start Date ^ICMJE

February 2004

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Both cohorts overall survival (OS) local control (LC) rate at six months and at one year [ Designated as safety issue: No ]
Cohort 1 only time-to-recurrence (TTR) [ Designated as safety issue: No ]
Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF) [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Drug: Gefitinib

Study Arms / Comparison Groups

Experimental: post operative combination of gefinib and RT
Experimental: combination of gefitinib with RT and Chemotherapy in non operated patients

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

March 2009

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00681967

Responsible Party

Madeleine Billeter, MD, Medical & Regulatory Affairs Director, AstraZeneca AG Switzerland

Study ID Numbers ^ICMJE

1839IL/0525

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP