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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

NCT00229723 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2009-08-04

Study results available
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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

DRUG

gefitinib (Iressa)

250 mg oral tablet

DRUG

cisplatin

intravenous infusion

RADIATION

radiotherapy

radiation therapy

DRUG

Gefitinib (Iressa)

500 mg oral tablet

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Oncology Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2008-06-30

Countries

  • United States
  • Belgium
  • Czechia
  • Germany
  • India
  • Poland
  • Serbia
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00229723 on ClinicalTrials.gov