NCT00229723

IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSA™) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.

Conditions

• Neoplasms, Squamous Cell

Interventions

Type	Name	Description
DRUG	gefitinib (Iressa)	250 mg oral tablet
DRUG	cisplatin	intravenous infusion
RADIATION	radiotherapy	radiation therapy
DRUG	Gefitinib (Iressa)	500 mg oral tablet

Timeline

• Start date: 2004-11-01
• Completion: 2008-06-01
• First posted: 2005-09-30
• Last updated: 2009-08-04
• Results posted: 2009-08-04

Locations

25 sites across 8 countries: United States, Belgium, Czechia, Germany, India, Poland, Serbia, Taiwan