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Randomized phase III trial of erlotinib versus docetaxel for patients with previously treated advanced non-small cell lung cancer

Phase 3
Conditions
Previously treated non-small cell lung cancer
Registration Number
JPRN-UMIN000002314
Lead Sponsor
ational Hospital Organization Headquarters Center for Support and Education of Clinical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

1)History of obvious distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT (Patients with radiation peumonitis limited to radiation field are eligible) 2)History of obvious drug induced interstitial pneumonia or pneumoconiosis 3)History of symptomatic brain metastases. Patients with brain metastases are eligible, if thier brain metastases are controlled by radiotherapy or drug therapy. 5)History of severe drug allergy 6)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 7)History of active infection or other serious disease condition (poorly controlled diabetes mellitus, poorly controlled cardiac disease, GI bleeding, cirrhosis, ileus, persistant watery diarrhea, etc) 8)History of active double cancer 9)History of active psychological disease. 10) History of pregnancy or lactation 11) Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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