Back to resultsIressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Primary Purpose
Head and Neck Cancer, Carcinoma, Squamous Cell
Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Iressa (Gefitinib)
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Squamous Cell Carcinoma of Head and Neck, Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
Eligibility Criteria
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)
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Secondary Outcome Measures
Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233636
Brief Title
Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Official Title
A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Carcinoma, Squamous Cell
Keywords
Squamous Cell Carcinoma of Head and Neck, Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iressa (Gefitinib)
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Secondary Outcome Measure Information:
Title
Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Italy Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aviano
Country
Italy
Facility Name
Research Site
City
Azienda
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Ragusa
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
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