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

Phase 1CompletedNCT00681967

AstraZeneca30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

GefitinibDRUG

250 mg; oral

GefitinibDRUG

250mg; oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Basel, Switzerland

Research Site

Bern, Switzerland

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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