Postoperative Radiotherapy Plus Iressa or Radiotherapy plus Cisplatin and Iressa for Advanced Head & Neck Cancer - IRESSA&H&N
Study identifier:1839IL/0525
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial
Medical condition
head and neck cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
Gefitinib
Sex
All
Actual Enrollment
30
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Feb 2004
Primary Completion Date: 01 Oct 2009
Study Completion Date: 01 Oct 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 post operative combination of gefinib and RT | Drug: Gefitinib 250 mg; oral Other Name: IRESSA (TM) |
| Experimental: Cohort 2 combination of gefitinib with RT and Chemotherapy in non operated patients | Drug: Gefitinib 250mg; oral Other Name: IRESSA (TM) |
Contacts
Investigators
Principal Investigator
Christoph Rochlitz
University Hospital of Basel
