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

Phase 2
Withdrawn
Conditions
Head and Neck Cancer
Carcinoma, Squamous Cell
Registration Number
NCT00233636
Lead Sponsor
AstraZeneca
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
28
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Secondary Outcome Measures
NameTimeMethod
Time to progression, Overall survival, Duration of response. Six months after Last Patient In.

Trial Locations

Locations (1)

Research Site

🇮🇹

Ragusa, Italy

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