Phase II study of 1st-line biweekly Gemcitabine and Carboplatin vs biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer
- Conditions
- advanced/recurrent non-small cell lung cancer (NSCLC)
- Registration Number
- JPRN-UMIN000039230
- Lead Sponsor
- Clinical Research Support Center Kyushu
- Brief Summary
mPFS(95%CI) control 4.99mo(3.29-6.28) maintenance 4.44mo(2.86-6.34) (p=0.47 log-rank)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 83
Not provided
(1) Patients with obvious infections (2) Patients with fever (38C or higher) (3) Serious complications (heart disease, pulmonary fibrosis/interstitial pneumonia, bleeding tendency, uncontrolled) Patients with hypertension, diabetes mellitus, etc. (4) Patients with active double cancer (disease-free interval <5 years) (5) Symptomatic patients with brain metastases (6) Patients with pleural effusions and ascites requiring treatment (7) Patients with pericardial effusion (8) Patients with varicella (9) Patients with motor paralysis or peripheral nerve symptoms (excluding those originating from the primary disease) (10) Patients with a history of drug hypersensitivity (11) Pregnant, breastfeeding, and women of childbearing potential (willingness) (12) Other patients judged inappropriate by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS
- Secondary Outcome Measures
Name Time Method