Carcinoma，Non-Small-Cell Lung
Conditions
Keywords
Non-Small-Cell Lung cancer, overall toxicity value
Brief summary
The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
Interventions
cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
DRUGnedaplatin+pemetrexed
nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology 2. The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy 3. Including one available evaluation lesion at least according to RECIST criteria 4. Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula). 5. Patients who had never received any antineoplastic therapy
Exclusion criteria
1. Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ 2. Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol 3. Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded） 4. Patient who has used chemotherapy before(bisphosphonate can be excluded ) 5. Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease 6. Patient who is allergic to drugs we need to use 7. Patients who are in pregnancy or lactation 8. AST or ALT 》2.5 \* upper limit of normal (ULN)，and ALP》5\*ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free-survival（PFS） | 12months | Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate （ORR） | 12months | ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR). |
| overall survival（OS） | 24 months | OS is defined as the time from the starting date of study drug to the date of death due to any cause |
| overall toxicity value | 12 months | toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 |
| Progression-Free Survival (PFS) rate at 18 weeks | 20 weeks | the proportion (%) of patients without disease progression at 18 weeks |
Countries
China
Contacts
Primary Contactli-kun chen, Doctor
Outcome results
None listed