IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
NCT ID: NCT00229723
Last Updated: 2009-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2004-11-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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1
Radiation + cisplatin; followed by placebo as maintenance therapy
cisplatin
intravenous infusion
radiotherapy
radiation therapy
2
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
gefitinib (Iressa)
250 mg oral tablet
cisplatin
intravenous infusion
radiotherapy
radiation therapy
3
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
cisplatin
intravenous infusion
radiotherapy
radiation therapy
Gefitinib (Iressa)
500 mg oral tablet
4
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
gefitinib (Iressa)
250 mg oral tablet
cisplatin
intravenous infusion
radiotherapy
radiation therapy
5
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
cisplatin
intravenous infusion
radiotherapy
radiation therapy
Gefitinib (Iressa)
500 mg oral tablet
6
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
gefitinib (Iressa)
250 mg oral tablet
cisplatin
intravenous infusion
radiotherapy
radiation therapy
7
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
cisplatin
intravenous infusion
radiotherapy
radiation therapy
Gefitinib (Iressa)
500 mg oral tablet
Interventions
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gefitinib (Iressa)
250 mg oral tablet
cisplatin
intravenous infusion
radiotherapy
radiation therapy
Gefitinib (Iressa)
500 mg oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior surgery or chemotherapy/biological therapy/radiation therapy
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy of more than 12 weeks
Exclusion Criteria
* Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Oncology Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Aurora, Colorado, United States
Research Site
Dallas, Texas, United States
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Hradec Králové, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Berlin, , Germany
Research Site
Essen, , Germany
Research Site
Münster, , Germany
Research Site
Saarbrücken, , Germany
Research Site
Bangalore, , India
Research Site
Mumbai, , India
Research Site
New Delhi, , India
Research Site
Thiruvananthapuram, , India
Research Site
Gliwice, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Warsaw, , Poland
Research Site
Belgrade, , Serbia
Research Site
Kamenitz, , Serbia
Research Site
Taipei, , Taiwan
Research Site
Taoynan, , Taiwan
Countries
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Other Identifiers
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EudraCT number 2004-000358-21
Identifier Type: -
Identifier Source: secondary_id
D7919C00706
Identifier Type: -
Identifier Source: secondary_id
1839IL/0706
Identifier Type: -
Identifier Source: org_study_id
NCT00099398
Identifier Type: -
Identifier Source: nct_alias
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