Randomized Phase 2 trial of Individualized Monotherapy based on CYFRA-21-1 serum levels before treatment Versus Pemetrexed Monotherapy in Older Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer and wild-type EGFR tumors
- Conditions
- Older patients with advanced nonsquamous non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000012292
- Lead Sponsor
- Kyoto Thoracic Oncology Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 3) History of drug-induced pneumonitis 4) History of poorly controlled pleural effusion,pericardial effusion and ascites 5) No oral supplement of folic acid and no injection of vitamin B12 6) Superior vena cava syndrome 7) Symptomatic brain metastasis 8) Uncontrollable hypertension or diabetes mellitus 9) History of severe heart disease (acute cardiac infarction or unstable angina within 6 months of registration, post-PTCA, post-CABG, sign of heart failure, uncontrollable arrythmia) 10) Severe drug allergy 11) History of active infection 12) Active concomitant cancers 13) Those judged to be not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6-month progression-free survival rate
- Secondary Outcome Measures
Name Time Method