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

AstraZeneca

Status and phase: Withdrawn; Phase 2

Conditions: Carcinoma, Squamous Cell; Head and Neck Cancer

Treatments: Drug: Iressa (Gefitinib); Procedure: Radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233636

1839IL/0070

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)