Randomized, Open-label, Phase III Study Comparing Pemetrexed with and without Carboplatin in Elderly Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0004170
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 266
Progressive non-small cell lung cancer (stage IV by AJCC 7 plate), except histologically or cytologically diagnosed squamous cell carcinoma
- If there is recurrence after surgery or radiation therapy but there is a measurement lesion and other local treatment is impossible
- Patients over 70 years of age
-Eastern Cooperative Oncology Group (ECOG) Full Body Performance (0-1)
- One or more lesions that can be measured or evaluated according to the RECIST 1.1 standard
- Life expectancy is over 3 months
- Appropriate bone marrow function: ANC =1.500 / ul, hemoglobin=9.0 g / dL (correctable by transfusion), and platelet =100.000 / ul, Adequate bone marrow function
- adequate renal function (Serum creatinine = 1xUNL or calculated cratinine clearnace = 45ml / min
- adequate liver function (Serum bilirubin = 1.25 x UNL, AST (SGOT) and ALT (SGPT) = 3 x UNL, alkaline phosphatase = 3 x UNL except bone metabolism with no epilepsy)
- Patients who voluntarily participated in this study and agreed to the written agreement
- Previous history of immunotherapy, biological or chemotherapy
- Penicillin on cefotaxime or carboflatin
- fluid retention (eg, pleural fluid or pericardial fluid) that is refractory to treatment or not clinically controlled
- Acute infection requiring antibiotic treatment
- Surgery requiring general anesthesia within 4 weeks of clinical trial
- Severe cardiovascular disease (ie uncontrolled hypertension, acute myocardial infarction within 6 months, unstable angina, congestive heart failure with NYHA grade 2 or greater, or severe arrhythmia)
- Stop pemetrexed doses of long-lived salycylates such as Asprin, nonsteroidal anti-inflammatory drugs (NSAIDs) or Cox-2 inhibitors (including NSAIDs or naproxen, piroxicam, diflunisal, naabumetone, rofecoxib, celecoxib) If you can not
- Patients with uncontrolled brain damage. (At least 2 weeks of radiation therapy or at least 1 week of surgery including gamma knife surgery, and steroid treatment at least 2 weeks before radiation therapy)
- Peripheral nerve lesion = grade 2
History of radiation therapy within 2 weeks
Other malignant diseases, including non-melanoma skin cancer, in situ cervical cancer, and thyroid cancer, which were cured within 5 years
- Patients who are pregnant or lactating
- If there is serious accompanying disease based on the judgment of other researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) comparison
- Secondary Outcome Measures
Name Time Method Comparison of response rate (RR);overall survival (OS);Quality-of-life (QoL);Charlson Comorbidity Index (CCI)