Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma
- Conditions
- Previously treated lung adeno carcinoma
- Registration Number
- JPRN-UMIN000002014
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 560
Not provided
1)History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of radiation therapy for mediastinum or lung within 14 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.) 5)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 6)History of active infection 7)History of persistent watery diarrhea 8)History of ileus 9)Patients who are not take in drug orally 10)History of symptomatic brain metastases. 11)History of active double cancer 12)History of poorly controlled cardiac diseases. 13)History of active psychological disease. 14) History of pregnancy or lactation 15) 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
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Response rate, disease control rate, Toxicity, Time to treatment failure,