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

Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681967

Acronym

IRESSA&H&N

Enrollment

Registered

2008-05-21

Start date

2004-02-29

Completion date

2009-10-31

Last updated

2010-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

squamous cell cancer of the head & neck, Gefitinib, IRESSA, EGFR Inhibitor, EGFR-tyrosine kinase inhibitor, Subjects with histologically proven squamous cell cancer of the head & neck, Cohort 1:qualifying for postoperative radiotherapy, (pT3, pT4, pN2b, pN2c, pN3)., Cohort 2:qualifying for definite chemoradiotherapy, (Lateral oropharynx, tonsils: T1N2b-3, T2N1-3, T3any N;, Base of tongue, vallecula: T1N1-3, T2-4 any N; Oral cavity,, glottic and supraglottic larynx; Any TN1-3, T3-4 any N;, Hypopharynx: T1N1-3, T2-4 and N)

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

Interventions

DRUGGefitinib

250 mg; oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026