Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233636

Enrollment

Registered

2005-10-06

Start date

2003-07-31

Completion date

Unknown

Last updated

2011-01-27

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

Conditions

Carcinoma, Squamous Cell, Head and Neck Cancer

Keywords

Squamous Cell Carcinoma of Head and Neck, Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck

Brief summary

The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Interventions

DRUGIressa (Gefitinib)

PROCEDURERadiotherapy

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

* Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck * At least one measurable tumour lesion

Exclusion criteria

* No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck * No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Design outcomes

Primary

Measure	Time frame
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.	—

Secondary

Measure	Time frame
Time to progression, Overall survival, Duration of response. Six months after Last Patient In.	—

Countries

Italy

Outcome results

None listed

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