chemotherapy-naive NSCLC
Conditions
Interventions
experiment arm:pemetrexed at 500mg/m2 over 10 min plus cisplatin 75mg/m2 on day 1
control:gemcitabine 1,000 mg/m2 on days 1 and 8 plus cisplatin 75mg/m2 on day 1
Sponsors
Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Eligible patients had histologically or cytologically confirmed, newly diagnosed unresectable stage IIIB/IV or recurrent (after surgery or radiotherapy) NSCLC; 2. patients with at least one unidimensionally measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors), had an Eastern Cooperative Oncology Group (ECOG); 3. with performance status of 0 or 1, had a life expectancy of at least 12 weeks; 4. Aged older than 18 years; 5. had adequate hematologic, hepatic and renal function; 6. Patients with CNS metastases were accepted, but patients with sympotomatic disease were not; 7. No other malignant tumor; 8. Stopping chemotherapy for more than 4 weeks; 9. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. pregnant/nursing women; history of other malignancies; 2. severe systemic disease that would potentially precluded chemotherapy treatment; 3. severe or uncontrolled conditions requiring medication or active infections; 4. and treatment with an investigational drug; 5. Patients were also excluded if they were unable to interrupt non-steroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or dexamethasone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Time to treatment failure;Overall response rate; | — |
Countries
China
Contacts
Public ContactYan SUN
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed