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

Phase 1

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Gefitinib

• Registration Number: NCT00681967
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-21
• Last Update Posted: 2010-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Gefitinib	post operative combination of gefinib and RT
Cohort 2	Gefitinib	combination of gefitinib with RT and Chemotherapy in non operated patients

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Both cohorts overall survival (OS) local control (LC) rate at six months and at one year
Cohort 1 only time-to-recurrence (TTR)
Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)

Trial Locations

Locations (1)

Research Site; 🇨🇭 Bern, Switzerland