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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681967
First received: May 20, 2008
Last updated: September 21, 2010
Last verified: September 2010

May 20, 2008
September 21, 2010
February 2004
October 2009   (final data collection date for primary 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681967 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: Gefitinib
    250 mg; oral
    Other Name: IRESSA (TM)
  • Drug: Gefitinib
    250mg; oral
    Other Name: IRESSA (TM)
  • Experimental: Cohort 1
    post operative combination of gefinib and RT
    Intervention: Drug: Gefitinib
  • Experimental: Cohort 2
    combination of gefitinib with RT and Chemotherapy in non operated patients
    Intervention: Drug: Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00681967
1839IL/0525
No
Dr. med. Dirk Schneider, AstraZeneca AG Switzerland
AstraZeneca
Not Provided
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
AstraZeneca
September 2010

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