Randomized Phase II trial of 1st-line biweekly Gemcitabine (G) and Carboplatin (C) vs biweekly Gemcitabine (G) and Carboplatin (C)plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)
Phase 2
- Conditions
- elderly patient untreated non-small cell lung cancer
- Registration Number
- JPRN-UMIN000004386
- Lead Sponsor
- ung Oncology Group in Kyushu, Japan (LOGIK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
Not provided
Exclusion Criteria
1)Overt infection 2)Febrile state (over 38 degree C) 3)Severe complicaiton including heart disease, pulmonary fibrosis, bleeding tendency, uncontrollable hypertension and diabetes mellitus 4)Double cancer 5)Symptomatic brain metastasis 6)Uncontrolled third-space fluid retention 7)Pericardial effusion 8)varicella virus infection 9)Peripheral neuropathy 10)Hypersensitivity drug reaction 11)Pregnant and nursing woman 12)Inappropriate to entry by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Response rate, Quality of life, Adverse events, Overall survival