Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
NCT ID: NCT00681967
Last Updated: 2010-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2004-02-29
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
post operative combination of gefinib and RT
Gefitinib
250 mg; oral
Cohort 2
combination of gefitinib with RT and Chemotherapy in non operated patients
Gefitinib
250mg; oral
Interventions
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Gefitinib
250 mg; oral
Gefitinib
250mg; oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age over 18 years
* Histologically proven squamous cell cancer of the head \& neck (SCCHN)
* Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3
Exclusion Criteria
* Tumour stage M1
* Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ
* Absolute neutrophil counts \<1.5 x 109
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca AG Switzerland
Principal Investigators
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Christoph Rochlitz, Prof Dr med
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Basel
Madeleine Billeter, MD
Role: STUDY_DIRECTOR
AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Verena Renggli
Role: STUDY_CHAIR
AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland
Locations
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Research Site
Basel, , Switzerland
Research Site
Bern, , Switzerland
Countries
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Other Identifiers
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1839IL/0525
Identifier Type: -
Identifier Source: org_study_id